TriangleNCT01390818 · OUTCOME
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- subjects
- Interval / dispersion
- Not reported
- Time frame
- From the date of randomisation every 6 weeks up to assessed up to 4 years
What was measured
CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.
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 (DE Cohort).
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 (DE Cohort).
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 (DE Cohort).
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 (DE Cohort).
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 (DE Cohort).
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
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).
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 (DE Cohort).
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 (DE Cohort).
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
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).
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
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).
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
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).
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 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 (DSE Cohort).
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule 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 (DSE Cohort).
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule 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 (DSE Cohort).
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule 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 (DSE Cohort).
| Group | Source count |
|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 3 |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 3 |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 3 |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 4 |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 4 |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 2 |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 13 |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 11 |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 2 |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 1 |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 3 |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 16 |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 20 |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 11 |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 14 |
Reported measurements
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 3 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 3 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 4 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 6 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 7 | Not reported | Not reported | Not reported | Not reported |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 10 | Not reported | Not reported | Not reported | Not reported |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 7 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 9 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 3 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 8 | Not reported | Not reported | Not reported | Not reported |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 6 | Not reported | Not reported | Not reported | Not reported |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 9 | Not reported | Not reported | Not reported | Not reported |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 4 | Not reported | Not reported | Not reported | Not reported |
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 2 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily | 0 | Not reported | Not reported | Not reported | Not reported |
| TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily | 3 | Not reported | Not reported | Not reported | Not reported |
| CRC: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
| MEL: Pimasertib 60mg and SAR245409 70mg Once Daily | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 7
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 8
- title
- Progressive disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 16
- units
- Participants
- description
- CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- 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 (DE Cohort).
- 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 (DE Cohort).
- 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 (DE Cohort).
- 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 (DE Cohort).
- 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 (DE Cohort).
- id
- OG004
- title
- Pimasertib (MSC1936369B) 60mg 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 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).
- id
- OG005
- title
- Pimasertib (MSC1936369B) 30mg and SAR245409 70mg 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 (DE Cohort).
- id
- OG006
- 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 (DE Cohort).
- id
- OG007
- title
- Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
- description
- 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).
- id
- OG008
- title
- Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
- description
- 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).
- id
- OG009
- title
- Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
- description
- 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).
- id
- OG010
- title
- Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
- description
- Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 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 (DSE Cohort).
- id
- OG011
- title
- TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
- param Type
- NUMBER
- population Description
- The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.
- reporting Status
- POSTED
- time Frame
- From the date of randomisation every 6 weeks up to assessed up to 4 years
- title
- Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)
- type
- SECONDARY
- unit Of Measure
- subjects
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