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NCT01390818 · OUTCOME

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of 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
hour*nanogram per millilitre (hr*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

What was measured

Area under the concentration-time curve from time 0 to the last quantifiable concentration.

Analysis population: The 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 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) 45mg Twice Daily

Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 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 Twice Daily

Pimasertib (MSC1936369B) capsule administered twice, orally, at a 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).

TNBC: Pimasertib 60mg Once Daily

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 (DSE Cohort).

NSCLC: Pimasertib 60mg Once Daily

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 (DSE Cohort).

CRC: Pimasertib 60mg Once Daily

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 (DSE Cohort).

MEL: Pimasertib 60mg Once Daily

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 (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, 25, 13, 4, 3, 25, 23, 18, 15)
Values in hour*nanogram per millilitre (hr*ng/mL) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg426.8Not reported306.2594.9Not reported
Pimasertib (MSC1936369B) 30mg734.4Not reported586.1920.3Not reported
Pimasertib (MSC1936369B) 60mg1547Not reported12381934Not reported
Pimasertib (MSC1936369B) 90mg2116Not reported16642692Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily326.1Not reported110.9958.7Not reported
Pimasertib (MSC1936369B) 60mg Twice Daily1252Not reported11001425Not reported
TNBC: Pimasertib 60mg Once Daily1781Not reported14042260Not reported
NSCLC: Pimasertib 60mg Once Daily1754Not reported14802078Not reported
CRC: Pimasertib 60mg Once Daily1709Not reported13612146Not reported
MEL: Pimasertib 60mg Once Daily1093Not reported871.51371Not reported
Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 10, 13)
Values in hour*nanogram per millilitre (hr*ng/mL) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg625.3Not reported405.7963.9Not reported
Pimasertib (MSC1936369B) 30mg902.0Not reported747.61088Not reported
Pimasertib (MSC1936369B) 60mg1617Not reported11702236Not reported
Pimasertib (MSC1936369B) 90mg2552Not reported21852980Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily773.1Not reported201.02974Not 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 Daily2136Not reported17132663Not reported
NSCLC: Pimasertib 60mg Once Daily1889Not reported15402318Not reported
CRC: Pimasertib 60mg Once Daily1988Not reported14872658Not reported
MEL: Pimasertib 60mg Once Daily1506Not reported11411988Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        306.2
        upper Limit
        594.9
        value
        426.8
      2. group Id
        OG001
        lower Limit
        586.1
        upper Limit
        920.3
        value
        734.4
      3. group Id
        OG002
        lower Limit
        1238
        upper Limit
        1934
        value
        1547
      4. group Id
        OG003
        lower Limit
        1664
        upper Limit
        2692
        value
        2116
      5. group Id
        OG004
        lower Limit
        110.9
        upper Limit
        958.7
        value
        326.1
      6. group Id
        OG005
        lower Limit
        1100
        upper Limit
        1425
        value
        1252
      7. group Id
        OG006
        lower Limit
        1404
        upper Limit
        2260
        value
        1781
      8. group Id
        OG007
        lower Limit
        1480
        upper Limit
        2078
        value
        1754
      9. group Id
        OG008
        lower Limit
        1361
        upper Limit
        2146
        value
        1709
      10. group Id
        OG009
        lower Limit
        871.5
        upper Limit
        1371
        value
        1093
    title
    Day 1 (n=6, 10, 25, 13, 4, 3, 25, 23, 18, 15)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        405.7
        upper Limit
        963.9
        value
        625.3
      2. group Id
        OG001
        lower Limit
        747.6
        upper Limit
        1088
        value
        902.0
      3. group Id
        OG002
        lower Limit
        1170
        upper Limit
        2236
        value
        1617
      4. group Id
        OG003
        lower Limit
        2185
        upper Limit
        2980
        value
        2552
      5. group Id
        OG004
        lower Limit
        201.0
        upper Limit
        2974
        value
        773.1
      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
        1713
        upper Limit
        2663
        value
        2136
      8. group Id
        OG007
        lower Limit
        1540
        upper Limit
        2318
        value
        1889
      9. group Id
        OG008
        lower Limit
        1487
        upper Limit
        2658
        value
        1988
      10. group Id
        OG009
        lower Limit
        1141
        upper Limit
        1988
        value
        1506
    title
    Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 10, 13)
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
description
Area under the concentration-time curve from time 0 to the last quantifiable concentration.
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 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
    Pimasertib (MSC1936369B) 90mg
  5. description
    Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 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
    Pimasertib (MSC1936369B) 45mg Twice Daily
  6. description
    Pimasertib (MSC1936369B) capsule administered twice, orally, at a 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
    OG005
    title
    Pimasertib (MSC1936369B) 60mg Twice Daily
  7. 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 (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 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: Pimasertib 60mg Once Daily
  9. 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 (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 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: Pimasertib 60mg Once Daily
param Type
GEOMETRIC_MEAN
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
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)
type
SECONDARY
unit Of Measure
hour*nanogram per millilitre (hr*ng/mL)

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Preserved source evidence · Not medical advice