Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.

The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.

→

secondary · POSTED

An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.

The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.

→

secondary · POSTED

Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)

The pharmacokinetic (PK) analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

→

secondary · POSTED

Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)

The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.

→

secondary · POSTED

Area under the concentration-time curve from time 0 to the last quantifiable concentration.

The PK analysis set . Here "n" signifies the number of subjects evaluable at the specific time points.

→

secondary · POSTED

Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz).

The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id: NCT01390818
trial label: Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 15
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
source section id
NCT01390818-om-0000
source outcome index
0
endpoint
Number of Subjects With Dose Limiting Toxicities (DLT)
endpoint definition
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.
time origin
Day 1 up to Day 16 in cycle 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0001
source section id
NCT01390818-om-0001
source outcome index
1
endpoint
Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)
endpoint definition
An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.
time origin
Baseline up to 30 Days after last dose; assessed up to 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0002
source section id
NCT01390818-om-0002
source outcome index
2
endpoint
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)
endpoint definition
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)
time origin
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The pharmacokinetic (PK) analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0003
source section id
NCT01390818-om-0003
source outcome index
3
endpoint
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)
endpoint definition
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)
time origin
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0004
source section id
NCT01390818-om-0004
source outcome index
4
endpoint
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)
endpoint definition
Area under the concentration-time curve from time 0 to the last quantifiable concentration.
time origin
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set . Here "n" signifies the number of subjects evaluable at the specific time points.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0005
source section id
NCT01390818-om-0005
source outcome index
5
endpoint
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1
endpoint definition
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz).
time origin
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG000
arm label
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
regimen
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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG001
arm label
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
regimen
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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG002
arm label
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
regimen
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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG003
arm label
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
regimen
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 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG004
arm label
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
regimen
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 (DE cohort).
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG005
arm label
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
regimen
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG006
arm label
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
regimen
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 (DE cohort).
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG007
arm label
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
regimen
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 (DE cohort).
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG008
arm label
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
regimen
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 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 (DE cohort).
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG009
arm label
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
regimen
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice 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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0000
arm key
OG010
arm label
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
regimen
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice 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 (DE cohort).
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
outcome key
om-0001
arm key
OG000
arm label
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
regimen
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 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 (DE cohort).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01390818-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG000
source section id
NCT01390818-ae
event group key
EG000
event group label
MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG001
source section id
NCT01390818-ae
event group key
EG001
event group label
MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG002
source section id
NCT01390818-ae
event group key
EG002
event group label
MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG003
source section id
NCT01390818-ae
event group key
EG003
event group label
MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG004
source section id
NCT01390818-ae
event group key
EG004
event group label
MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG005
source section id
NCT01390818-ae
event group key
EG005
event group label
MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG006
source section id
NCT01390818-ae
event group key
EG006
event group label
MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily
serious affected
14
serious at risk
19
other affected
19
other at risk
19
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG007
source section id
NCT01390818-ae
event group key
EG007
event group label
MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily
serious affected
10
serious at risk
14
other affected
14
other at risk
14
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG008
source section id
NCT01390818-ae
event group key
EG008
event group label
MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG009
source section id
NCT01390818-ae
event group key
EG009
event group label
MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG010
source section id
NCT01390818-ae
event group key
EG010
event group label
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily
serious affected
3
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT01390818
harm key
EG011
source section id
NCT01390818-ae
event group key
EG011
event group label
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
serious affected
16
serious at risk
26
other affected
26
other at risk
26
frequency threshold
0
collection period
Baseline up to 30 Days after last dose; assessed up to 4 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice