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NCT01390818 · OUTCOME

Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)

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
NUMBER
Unit
subjects
Interval / dispersion
Not reported
Time frame
Baseline up to 30 Days after last dose; assessed up to 4 years

What was measured

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.

Analysis population: 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.

Groups in this outcome

Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily

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).

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 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) 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 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) 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 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) 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 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 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 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) 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 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 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 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 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).

MSC1936369B (Pimasertib) 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.

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 each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.

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 each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.

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 each 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

GroupSource count
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily3
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily3
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily3
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily4
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily4
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily3
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily19
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily14
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily3
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily3
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily4
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily26
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily24
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily18
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily15

Reported measurements

Source class 1
Values in subjects · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily3Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily3Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily3Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily4Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily4Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily3Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily19Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily14Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily3Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily3Not reportedNot reportedNot reportedNot reported
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily4Not reportedNot reportedNot reportedNot reported
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily26Not reportedNot reportedNot reportedNot reported
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily24Not reportedNot reportedNot reportedNot reported
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily18Not reportedNot reportedNot reportedNot reported
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        19
      8. group Id
        OG007
        value
        14
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        26
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      19
    8. group Id
      OG007
      value
      14
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      26
    units
    Participants
description
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.
groups
  1. description
    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).
    id
    OG000
    title
    Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
  2. 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 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
    OG001
    title
    Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
  3. 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 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
    OG002
    title
    Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
  4. 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
  5. 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 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
    OG004
    title
    Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
  6. 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 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
    OG005
    title
    Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
  7. 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 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
    OG006
    title
    Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
  8. 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 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
    OG007
    title
    Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
  9. 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 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
    OG008
    title
    Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
  10. 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
  11. 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
    MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily
  12. 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.
    id
    OG011
    title
    TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
Baseline up to 30 Days after last dose; assessed up to 4 years
title
Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
subjects

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

Preserved source evidence · Not medical advice