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NCT01390818 · OUTCOME

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

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
GEOMETRIC_MEAN
Unit
nanogram/millilitre (ng/mL)
Interval / dispersion
95% Confidence Interval
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

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

Groups in this outcome

Pimasertib (MSC1936369B) 15mg

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 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).

Pimasertib (MSC1936369B) 30mg

Pimasertib (MSC1936369B) capsule administered at a single oral 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).

Pimasertib (MSC1936369B) 60mg

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 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).

Pimasertib (MSC1936369B) 90mg

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).

Pimasertib (MSC1936369B) 45mg Twice Daily

Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).

Pimasertib (MSC1936369B) 60mg Twice Daily

Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).

TNBC: Pimasertib 60mg Once Daily

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

NSCLC: Pimasertib 60mg Once Daily

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

CRC: Pimasertib 60mg Once Daily

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).

MEL: Pimasertib 60mg Once Daily

Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 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
Pimasertib (MSC1936369B) 15mg6
Pimasertib (MSC1936369B) 30mg10
Pimasertib (MSC1936369B) 60mg26
Pimasertib (MSC1936369B) 90mg14
Pimasertib (MSC1936369B) 45mg Twice Daily4
Pimasertib (MSC1936369B) 60mg Twice Daily3
TNBC: Pimasertib 60mg Once Daily26
NSCLC: Pimasertib 60mg Once Daily24
CRC: Pimasertib 60mg Once Daily18
MEL: Pimasertib 60mg Once Daily15

Reported measurements

Day 1 (n=6, 10, 26, 13, 4, 3, 25, 23, 18, 15)
Values in nanogram/millilitre (ng/mL) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg86.06Not reported51.31144.3Not reported
Pimasertib (MSC1936369B) 30mg188.2Not reported138.5255.9Not reported
Pimasertib (MSC1936369B) 60mg246.1Not reported191.8315.6Not reported
Pimasertib (MSC1936369B) 90mg406.9Not reported284.6581.7Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily83.72Not reported18.05388.3Not reported
Pimasertib (MSC1936369B) 60mg Twice Daily232.5Not reported190.9283.2Not reported
TNBC: Pimasertib 60mg Once Daily323.1Not reported253.9411.1Not reported
NSCLC: Pimasertib 60mg Once Daily295.4Not reported240.9362.2Not reported
CRC: Pimasertib 60mg Once Daily245.6Not reported198.5304.0Not reported
MEL: Pimasertib 60mg Once Daily234.0Not reported182.6299.8Not reported
Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 13, 10)
Values in nanogram/millilitre (ng/mL) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg131.3Not reported85.13202.6Not reported
Pimasertib (MSC1936369B) 30mg212.8Not reported178.9253.1Not reported
Pimasertib (MSC1936369B) 60mg234.2Not reported166.2330.1Not reported
Pimasertib (MSC1936369B) 90mg516.4Not reported375.0711.0Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily143.1Not reported22.82897.8Not reported
Pimasertib (MSC1936369B) 60mg 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.
TNBC: Pimasertib 60mg Once Daily320.5Not reported286.2358.9Not reported
NSCLC: Pimasertib 60mg Once Daily327.6Not reported248.5431.9Not reported
CRC: Pimasertib 60mg Once Daily307.7Not reported205.0461.8Not reported
MEL: Pimasertib 60mg Once Daily338.9Not reported281.0408.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.31
        upper Limit
        144.3
        value
        86.06
      2. group Id
        OG001
        lower Limit
        138.5
        upper Limit
        255.9
        value
        188.2
      3. group Id
        OG002
        lower Limit
        191.8
        upper Limit
        315.6
        value
        246.1
      4. group Id
        OG003
        lower Limit
        284.6
        upper Limit
        581.7
        value
        406.9
      5. group Id
        OG004
        lower Limit
        18.05
        upper Limit
        388.3
        value
        83.72
      6. group Id
        OG005
        lower Limit
        190.9
        upper Limit
        283.2
        value
        232.5
      7. group Id
        OG006
        lower Limit
        253.9
        upper Limit
        411.1
        value
        323.1
      8. group Id
        OG007
        lower Limit
        240.9
        upper Limit
        362.2
        value
        295.4
      9. group Id
        OG008
        lower Limit
        198.5
        upper Limit
        304.0
        value
        245.6
      10. group Id
        OG009
        lower Limit
        182.6
        upper Limit
        299.8
        value
        234.0
    title
    Day 1 (n=6, 10, 26, 13, 4, 3, 25, 23, 18, 15)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.13
        upper Limit
        202.6
        value
        131.3
      2. group Id
        OG001
        lower Limit
        178.9
        upper Limit
        253.1
        value
        212.8
      3. group Id
        OG002
        lower Limit
        166.2
        upper Limit
        330.1
        value
        234.2
      4. group Id
        OG003
        lower Limit
        375.0
        upper Limit
        711.0
        value
        516.4
      5. group Id
        OG004
        lower Limit
        22.82
        upper Limit
        897.8
        value
        143.1
      6. 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
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. group Id
        OG006
        lower Limit
        286.2
        upper Limit
        358.9
        value
        320.5
      8. group Id
        OG007
        lower Limit
        248.5
        upper Limit
        431.9
        value
        327.6
      9. group Id
        OG008
        lower Limit
        205.0
        upper Limit
        461.8
        value
        307.7
      10. group Id
        OG009
        lower Limit
        281.0
        upper Limit
        408.8
        value
        338.9
    title
    Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 13, 10)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      26
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      3
    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
dispersion Type
95% Confidence Interval
groups
  1. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 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
    Pimasertib (MSC1936369B) 15mg
  2. description
    Pimasertib (MSC1936369B) capsule administered at a single oral 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
    OG001
    title
    Pimasertib (MSC1936369B) 30mg
  3. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 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
    Pimasertib (MSC1936369B) 60mg
  4. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 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) 90mg
  5. description
    Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 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) 45mg Twice Daily
  6. description
    Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 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) 60mg Twice Daily
  7. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG006
    title
    TNBC: Pimasertib 60mg Once Daily
  8. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG007
    title
    NSCLC: Pimasertib 60mg Once Daily
  9. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG008
    title
    CRC: Pimasertib 60mg Once Daily
  10. description
    Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
    id
    OG009
    title
    MEL: Pimasertib 60mg Once Daily
param Type
GEOMETRIC_MEAN
population Description
The pharmacokinetic (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
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)
type
SECONDARY
unit Of Measure
nanogram/millilitre (ng/mL)

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Preserved source evidence · Not medical advice