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NCT01390818 · OUTCOME

Number of Subjects With Dose Limiting Toxicities (DLT)

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
Day 1 up to Day 16 in cycle 1

What was measured

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.

Analysis population: 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.

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 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).

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 Daily3
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily2
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily3
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily11
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily11
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily2
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily3
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily4

Reported measurements

Source class 1
Values in subjects · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily0Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily2Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily1Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily2Not reportedNot reportedNot reportedNot reported
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        1
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
      3
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      11
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      3
    11. group Id
      OG010
      value
      4
    units
    Participants
description
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.
groups
  1. 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
  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 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 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 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 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 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 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 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 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
    Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
Day 1 up to Day 16 in cycle 1
title
Number of Subjects With Dose Limiting Toxicities (DLT)
type
PRIMARY
unit Of Measure
subjects

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

Preserved source evidence · Not medical advice