Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors · Source last updated 2017-03-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
fluorescence intensity
Interval / dispersion
Standard Deviation
Time frame
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
What was measured
pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
Analysis population: Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "N" signifies number of subject analysed for this outcome measure" and "n" signifies number of subject analysed at specific time point.
Groups in this outcome
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
1
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
1
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
1
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
3
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
1
Reported measurements
DDI Day 1: Predose (n= 1, 0, 0, 0, 0, 0, 1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.77
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
10.55
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 2 hr post-dose (n=1,0,0,0,0.0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
8.74
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
10.17
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 4 hr post-dose ((n=1,0,0,0,0,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.10
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
6.50
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
7.42
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
9.36
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 24 hr post-dose (n=1,0,0,0,0,0,0)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
10.84
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 2: 24 hr post-dose ((n= 0,0,0,0,0,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
8.32
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
9.46
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
8.94
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 3: 2 hr post-dose (n=1,0,0,0,0,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
3.12
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
15.82
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 3: 4 hr post-dose (n-1,0,0,0,0,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.74
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.68
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 3: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
0.81
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
15.68
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
DDI Day 3: 24 hr post-dose (n=1,0,0,0,0,0,0)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.18
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 4: 24 hr post-dose (n=0,0,0,0,0,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
1.06
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D1: Pre dose (n=1,1,1,1,1,1,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
5.56
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
3.45
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
6.96
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
3.25
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
3.35
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
1.97
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
7.42
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D1: 2hr postdose(n= 1,1,1,1,1,1,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
2.37
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
1.33
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
2.78
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.54
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.40
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
0.95
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
1.04
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D1: 4hr postdose(n= 1,1,1,1,1,1,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
2.85
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
1.37
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
2.91
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.24
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.96
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
1.11
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
1.01
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D1: 8hr postdose(n= 1,1,1,1,1,1,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
0.67
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
0.94
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
3.40
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.96
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.27
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
1.12
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.82
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D1: 24hr postdose(n= 1,1,1,1,0,0,0)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.23
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
2.15
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
4.59
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
6.26
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D2: 24hr postdose(n= 0,0,0,0,1,1,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
3.45
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
1.26
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
1.05
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D15: pre-dose(n= 1,1,1,1,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
3.79
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
2.26
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
5.29
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.41
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.93
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
2.03
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D15: 2hr postdose (n= 1,1,1,1,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
2.16
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
1.34
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
2.83
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.60
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.55
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.94
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D15: 4hr postdose (n= 1,1,1,1,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
1.87
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
1.34
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
2.50
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
0.94
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.20
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.81
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D15: 8hr postdose (n= 1,1,1,1,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
1.92
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
2.08
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
3.38
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
1.10
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
1.74
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.99
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D15: 24hr postdose (n= 1,1,1,1,0,0,0)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
4.97
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
0.94
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
5.33
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
4.70
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D16: 24hr postdose (n= 0,0,0,0,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
2.36
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
0.99
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D19: pre-dose (n= 1,1,1,1,1,0,1)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
6.54
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
2.61
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
4.47
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
5.44
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
2.07
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
5.72
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
C1D19: 2hr postdose (n= 1,0,0,0,0,0,0)
Values in fluorescence intensity · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
1.60
NA
Not reported
Not reported
Data for standard deviation was not estimable as only one subject analyzed.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
NA
NA
Not reported
Not reported
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Complete source fields
classes
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
6.77
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
10.55
title
DDI Day 1: Predose (n= 1, 0, 0, 0, 0, 0, 1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
8.74
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
10.17
title
DDI Day 1: 2 hr post-dose (n=1,0,0,0,0.0,1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
6.10
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
6.50
title
DDI Day 1: 4 hr post-dose ((n=1,0,0,0,0,0,1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
7.42
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
9.36
title
DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
10.84
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG006
spread
NA
value
NA
title
DDI Day 1: 24 hr post-dose (n=1,0,0,0,0,0,0)
categories
measurements
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG000
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
8.32
title
DDI Day 2: 24 hr post-dose ((n= 0,0,0,0,0,0,1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
9.46
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
8.94
title
DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
3.12
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
15.82
title
DDI Day 3: 2 hr post-dose (n=1,0,0,0,0,0,1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
6.74
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
0.68
title
DDI Day 3: 4 hr post-dose (n-1,0,0,0,0,0,1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
0.81
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
15.68
title
DDI Day 3: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
categories
measurements
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG000
spread
NA
value
6.18
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG006
spread
NA
value
NA
title
DDI Day 3: 24 hr post-dose (n=1,0,0,0,0,0,0)
categories
measurements
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG000
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG001
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG002
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG003
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG004
spread
NA
value
NA
comment
The parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
group Id
OG005
spread
NA
value
NA
comment
Data for standard deviation was not estimable as only one subject analyzed.
group Id
OG006
spread
NA
value
1.06
title
DDI Day 4: 24 hr post-dose (n=0,0,0,0,0,0,1)
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
3
group Id
OG006
value
1
units
Participants
description
pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
dispersion Type
Standard Deviation
groups
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG000
title
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG001
title
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG002
title
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG003
title
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject
id
OG004
title
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG005
title
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
description
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
id
OG006
title
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
param Type
MEAN
population Description
Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "N" signifies number of subject analysed for this outcome measure" and "n" signifies number of subject analysed at specific time point.
reporting Status
POSTED
time Frame
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
Triangle