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NCT01390818 · OUTCOME

Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) 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
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

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, 26, 13, 3, 3, 24, 23, 17,13)
Values in hr*ng/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg426.8Not reported306.2594.9Not reported
Pimasertib (MSC1936369B) 30mg742.1Not reported602.0914.7Not reported
Pimasertib (MSC1936369B) 60mg1547Not reported12381934Not reported
Pimasertib (MSC1936369B) 90mg2116Not reported16642692Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily354.9Not reported48.212613Not reported
Pimasertib (MSC1936369B) 60mg Twice Daily1252Not reported11001425Not reported
TNBC: Pimasertib 60mg Once Daily1882Not reported15132341Not reported
NSCLC: Pimasertib 60mg Once Daily1754Not reported14802078Not reported
CRC: Pimasertib 60mg Once Daily1772Not reported14092227Not reported
MEL: Pimasertib 60mg Once Daily1093Not reported871.51371Not reported
Day 15 (n=6, 9, 15, 9, 3, 0, 16, 17, 10, 13)
Values in hr*ng/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg650.4Not reported440.1961.2Not 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 could not be calculated because there were no subjects evaluated for this arm at the specified time point.
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
        602.0
        upper Limit
        914.7
        value
        742.1
      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
        48.21
        upper Limit
        2613
        value
        354.9
      6. group Id
        OG005
        lower Limit
        1100
        upper Limit
        1425
        value
        1252
      7. group Id
        OG006
        lower Limit
        1513
        upper Limit
        2341
        value
        1882
      8. group Id
        OG007
        lower Limit
        1480
        upper Limit
        2078
        value
        1754
      9. group Id
        OG008
        lower Limit
        1409
        upper Limit
        2227
        value
        1772
      10. group Id
        OG009
        lower Limit
        871.5
        upper Limit
        1371
        value
        1093
    title
    Day 1 (n= 6, 10, 26, 13, 3, 3, 24, 23, 17,13)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        440.1
        upper Limit
        961.2
        value
        650.4
      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 could not be calculated because there were no subjects evaluated for this arm at the specified time point.
        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, 0, 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
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 Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)
type
SECONDARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice