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NCT01390818 · OUTCOME

Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409

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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
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

What was measured

The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.

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

Groups in this outcome

SAR245409 30mg

SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

SAR245409 50mg

SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

SAR245409 70mg

SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

SAR245409 90mg

SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

SAR245409 30mg Twice Daily

SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

SAR245409 50mg Twice Daily

SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).

TNBC: SAR245409 70mg Once Daily

SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

NSCLC: SAR245409 70mg Once Daily

SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

CRC: SAR245409 70mg Once Daily

SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

MEL: SAR245409 70mg Once Daily

SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE 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
SAR245409 30mg6
SAR245409 50mg11
SAR245409 70mg36
SAR245409 90mg3
SAR245409 30mg Twice Daily3
SAR245409 50mg Twice Daily4
TNBC: SAR245409 70mg Once Daily26
NSCLC: SAR245409 70mg Once Daily24
CRC: SAR245409 70mg Once Daily18
MEL: SAR245409 70mg Once Daily15

Reported measurements

Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SAR245409 30mg1.510Not reported0.532.08Not reported
SAR245409 50mg1.150Not reported0.504.10Not reported
SAR245409 70mg1.500Not reported0.5023.80Not reported
SAR245409 90mg1.500Not reported1.008.00Not reported
SAR245409 30mg Twice Daily2.050Not reported1.502.07Not reported
SAR245409 50mg Twice Daily1.540Not reported0.504.00Not reported
TNBC: SAR245409 70mg Once Daily1.500Not reported0.528.03Not reported
NSCLC: SAR245409 70mg Once Daily2.000Not reported0.504.17Not reported
CRC: SAR245409 70mg Once Daily2.000Not reported0.438.05Not reported
MEL: SAR245409 70mg Once Daily1.500Not reported0.954.00Not reported
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
SAR245409 30mg1.265Not reported1.002.00Not reported
SAR245409 50mg1.750Not reported0.533.00Not reported
SAR245409 70mg1.970Not reported1.008.13Not reported
SAR245409 90mgNANot reportedNANAData was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
SAR245409 30mg Twice DailyNANot reportedNANAData was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
SAR245409 50mg Twice Daily1.550Not reported1.508.00Not reported
TNBC: SAR245409 70mg Once Daily2.030Not reported0.527.98Not reported
NSCLC: SAR245409 70mg Once Daily1.530Not reported0.928.00Not reported
CRC: SAR245409 70mg Once Daily1.750Not reported0.508.00Not reported
MEL: SAR245409 70mg Once Daily1.050Not reported0.503.97Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        2.08
        value
        1.510
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        4.10
        value
        1.150
      3. group Id
        OG002
        lower Limit
        0.50
        upper Limit
        23.80
        value
        1.500
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        8.00
        value
        1.500
      5. group Id
        OG004
        lower Limit
        1.50
        upper Limit
        2.07
        value
        2.050
      6. group Id
        OG005
        lower Limit
        0.50
        upper Limit
        4.00
        value
        1.540
      7. group Id
        OG006
        lower Limit
        0.52
        upper Limit
        8.03
        value
        1.500
      8. group Id
        OG007
        lower Limit
        0.50
        upper Limit
        4.17
        value
        2.000
      9. group Id
        OG008
        lower Limit
        0.43
        upper Limit
        8.05
        value
        2.000
      10. group Id
        OG009
        lower Limit
        0.95
        upper Limit
        4.00
        value
        1.500
    title
    Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        2.00
        value
        1.265
      2. group Id
        OG001
        lower Limit
        0.53
        upper Limit
        3.00
        value
        1.750
      3. group Id
        OG002
        lower Limit
        1.00
        upper Limit
        8.13
        value
        1.970
      4. comment
        Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. group Id
        OG005
        lower Limit
        1.50
        upper Limit
        8.00
        value
        1.550
      7. group Id
        OG006
        lower Limit
        0.52
        upper Limit
        7.98
        value
        2.030
      8. group Id
        OG007
        lower Limit
        0.92
        upper Limit
        8.00
        value
        1.530
      9. group Id
        OG008
        lower Limit
        0.50
        upper Limit
        8.00
        value
        1.750
      10. group Id
        OG009
        lower Limit
        0.50
        upper Limit
        3.97
        value
        1.050
    title
    Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      36
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      26
    8. group Id
      OG007
      value
      24
    9. group Id
      OG008
      value
      18
    10. group Id
      OG009
      value
      15
    units
    Participants
description
The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.
dispersion Type
Full Range
groups
  1. description
    SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG000
    title
    SAR245409 30mg
  2. description
    SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG001
    title
    SAR245409 50mg
  3. description
    SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG002
    title
    SAR245409 70mg
  4. description
    SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG003
    title
    SAR245409 90mg
  5. description
    SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG004
    title
    SAR245409 30mg Twice Daily
  6. description
    SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
    id
    OG005
    title
    SAR245409 50mg Twice Daily
  7. description
    SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG006
    title
    TNBC: SAR245409 70mg Once Daily
  8. description
    SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG007
    title
    NSCLC: SAR245409 70mg Once Daily
  9. description
    SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG008
    title
    CRC: SAR245409 70mg Once Daily
  10. description
    SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG009
    title
    MEL: SAR245409 70mg Once Daily
param Type
MEDIAN
population Description
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
reporting Status
POSTED
time Frame
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
title
Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice