NCT01390818 · OUTCOME

pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)

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); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)

What was measured

pS6 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: The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "n" signifies the number of subjects evaluable at the specific time points.

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: 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	61.02	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	33.78	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI Day 1: 2hr 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	36.15	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	29.84	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI Day 1: 4hr 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	89.14	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	30.28	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	54.54	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	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	44.88	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI Day 1: 24hr 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	88.80	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: 24hr 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	28.86	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	57.51	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	14.90	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI Day 3: 2hr 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	55.93	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	34.06	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI Day 3: 4hr 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	36.76	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	1.03	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	1.08	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	40.40	NA	Not reported	Not reported	Data for standard deviation was not estimable as only one subject analyzed.

DDI:Day 3: 24hr 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	87.60	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.

DDI Day 4: 24hr 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	1.04	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	51.32	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	83.52	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	96.98	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	47.09	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	50.17	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	4.18	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	36.03	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	31.08	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	24.48	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	56.41	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	23.89	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	5.72	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	0.92	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	25.71	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	46.95	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	50.11	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	29.85	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	18.21	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	0.72	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	0.94	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	3.02	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	1.28	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	84.57	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	19.75	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	6.21	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	1.18	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	0.96	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	46.16	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	72.14	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	74.15	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	53.47	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	24.66	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	1.61	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	1.00	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	43.48	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	81.29	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	67.69	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	1.20	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	33.43	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	0.98	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	26.41	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	43.70	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	48.23	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	15.02	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	21.11	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	1.06	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	41.34	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	53.37	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	92.67	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	0.96	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	19.68	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	1.03	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	0.53	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	45.97	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	77.62	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	36.06	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	30.08	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	0.88	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	69.93	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	0.76	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	114.39	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	70.46	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	24.36	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	0.98	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	68.48	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	90.02	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	125.77	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	82.06	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	30.58	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	49.62	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	4.34	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
61.02
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
33.78
title
DDI Day 1: 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
36.15
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
29.84
title
DDI Day 1: 2hr 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
89.14
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
30.28
title
DDI Day 1: 4hr 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
54.54
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
44.88
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
88.80
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: 24hr 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
28.86
title
DDI Day 2: 24hr 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
57.51
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
14.90
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
55.93
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
34.06
title
DDI Day 3: 2hr 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
36.76
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
1.03
title
DDI Day 3: 4hr 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
1.08
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
40.40
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
87.60
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: 24hr 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
1.04
title
DDI Day 4: 24hr 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

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

The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "n" signifies the number of subjects evaluable at the specific time points.

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); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)

title

pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)

type

SECONDARY

unit Of Measure

fluorescence intensity

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice