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NCT01390818 · OUTCOME

Half-Life (t1/2) of MSC1936369B (Pimasertib)

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
hour
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

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, 9, 23, 13, 4, 3, 22, 22, 15, 13)
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg6.250Not reported5.037.16Not reported
Pimasertib (MSC1936369B) 30mg4.670Not reported1.855.79Not reported
Pimasertib (MSC1936369B) 60mg4.840Not reported3.239.99Not reported
Pimasertib (MSC1936369B) 90mg4.800Not reported3.497.62Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily3.320Not reported2.604.72Not reported
Pimasertib (MSC1936369B) 60mg Twice Daily4.640Not reported4.254.74Not reported
TNBC: Pimasertib 60mg Once Daily4.840Not reported2.468.41Not reported
NSCLC: Pimasertib 60mg Once Daily4.370Not reported3.718.26Not reported
CRC: Pimasertib 60mg Once Daily4.770Not reported3.5112.8Not reported
MEL: Pimasertib 60mg Once Daily4.240Not reported3.324.84Not reported
Day 15 (n=6, 9, 14, 9, 2, 1, 16, 16, 9, 12)
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg5.855Not reported2.937.88Not reported
Pimasertib (MSC1936369B) 30mg5.410Not reported3.9010.8Not reported
Pimasertib (MSC1936369B) 60mg6.755Not reported4.6114.3Not reported
Pimasertib (MSC1936369B) 90mg5.590Not reported3.9714.1Not reported
Pimasertib (MSC1936369B) 45mg 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.
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 Daily5.210Not reported3.2512.8Not reported
NSCLC: Pimasertib 60mg Once Daily5.250Not reported4.338.65Not reported
CRC: Pimasertib 60mg Once Daily5.210Not reported4.806.94Not reported
MEL: Pimasertib 60mg Once Daily4.325Not reported3.405.96Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.03
        upper Limit
        7.16
        value
        6.250
      2. group Id
        OG001
        lower Limit
        1.85
        upper Limit
        5.79
        value
        4.670
      3. group Id
        OG002
        lower Limit
        3.23
        upper Limit
        9.99
        value
        4.840
      4. group Id
        OG003
        lower Limit
        3.49
        upper Limit
        7.62
        value
        4.800
      5. group Id
        OG004
        lower Limit
        2.60
        upper Limit
        4.72
        value
        3.320
      6. group Id
        OG005
        lower Limit
        4.25
        upper Limit
        4.74
        value
        4.640
      7. group Id
        OG006
        lower Limit
        2.46
        upper Limit
        8.41
        value
        4.840
      8. group Id
        OG007
        lower Limit
        3.71
        upper Limit
        8.26
        value
        4.370
      9. group Id
        OG008
        lower Limit
        3.51
        upper Limit
        12.8
        value
        4.770
      10. group Id
        OG009
        lower Limit
        3.32
        upper Limit
        4.84
        value
        4.240
    title
    Day 1 (n=6, 9, 23, 13, 4, 3, 22, 22, 15, 13)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.93
        upper Limit
        7.88
        value
        5.855
      2. group Id
        OG001
        lower Limit
        3.90
        upper Limit
        10.8
        value
        5.410
      3. group Id
        OG002
        lower Limit
        4.61
        upper Limit
        14.3
        value
        6.755
      4. group Id
        OG003
        lower Limit
        3.97
        upper Limit
        14.1
        value
        5.590
      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. 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
        3.25
        upper Limit
        12.8
        value
        5.210
      8. group Id
        OG007
        lower Limit
        4.33
        upper Limit
        8.65
        value
        5.250
      9. group Id
        OG008
        lower Limit
        4.80
        upper Limit
        6.94
        value
        5.210
      10. group Id
        OG009
        lower Limit
        3.40
        upper Limit
        5.96
        value
        4.325
    title
    Day 15 (n=6, 9, 14, 9, 2, 1, 16, 16, 9, 12)
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
Full Range
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
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
Half-Life (t1/2) of MSC1936369B (Pimasertib)
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice