Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01390818 · OUTCOME

Total Body Clearance (CL/f) 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
litre per hour (L/hr)
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

The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.

Analysis population: The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "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 Daily1
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, 0, 22, 22, 14, 13)
Values in litre per hour (L/hr) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg33.22Not reported23.5246.92Not reported
Pimasertib (MSC1936369B) 30mg38.90Not reported30.2650.00Not reported
Pimasertib (MSC1936369B) 60mg37.99Not reported29.3349.22Not reported
Pimasertib (MSC1936369B) 90mg40.88Not reported31.8552.47Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily89.49Not reported27.14295.1Not 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 Daily32.12Not reported24.9541.36Not reported
NSCLC: Pimasertib 60mg Once Daily32.75Not reported27.1639.50Not reported
CRC: Pimasertib 60mg Once Daily30.75Not reported23.4140.41Not reported
MEL: Pimasertib 60mg Once Daily53.94Not reported41.6169.62Not reported
Day 15 (n=6, 9, 15, 9, 3, 1, 16, 17, 10, 13)
Values in litre per hour (L/hr) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pimasertib (MSC1936369B) 15mg23.06Not reported15.5934.10Not reported
Pimasertib (MSC1936369B) 30mg33.30Not reported27.6340.13Not reported
Pimasertib (MSC1936369B) 60mg37.11Not reported26.8251.33Not reported
Pimasertib (MSC1936369B) 90mg35.28Not reported30.1941.23Not reported
Pimasertib (MSC1936369B) 45mg Twice Daily58.22Not reported15.03225.6Not 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 Daily28.11Not reported22.5435.07Not reported
NSCLC: Pimasertib 60mg Once Daily31.73Not reported25.8538.94Not reported
CRC: Pimasertib 60mg Once Daily30.20Not reported22.5940.38Not reported
MEL: Pimasertib 60mg Once Daily39.81Not reported30.1752.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.52
        upper Limit
        46.92
        value
        33.22
      2. group Id
        OG001
        lower Limit
        30.26
        upper Limit
        50.00
        value
        38.90
      3. group Id
        OG002
        lower Limit
        29.33
        upper Limit
        49.22
        value
        37.99
      4. group Id
        OG003
        lower Limit
        31.85
        upper Limit
        52.47
        value
        40.88
      5. group Id
        OG004
        lower Limit
        27.14
        upper Limit
        295.1
        value
        89.49
      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
        24.95
        upper Limit
        41.36
        value
        32.12
      8. group Id
        OG007
        lower Limit
        27.16
        upper Limit
        39.50
        value
        32.75
      9. group Id
        OG008
        lower Limit
        23.41
        upper Limit
        40.41
        value
        30.75
      10. group Id
        OG009
        lower Limit
        41.61
        upper Limit
        69.62
        value
        53.94
    title
    Day 1 (n=6, 10, 26, 13, 3, 0, 22, 22, 14, 13)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.59
        upper Limit
        34.10
        value
        23.06
      2. group Id
        OG001
        lower Limit
        27.63
        upper Limit
        40.13
        value
        33.30
      3. group Id
        OG002
        lower Limit
        26.82
        upper Limit
        51.33
        value
        37.11
      4. group Id
        OG003
        lower Limit
        30.19
        upper Limit
        41.23
        value
        35.28
      5. group Id
        OG004
        lower Limit
        15.03
        upper Limit
        225.6
        value
        58.22
      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
        22.54
        upper Limit
        35.07
        value
        28.11
      8. group Id
        OG007
        lower Limit
        25.85
        upper Limit
        38.94
        value
        31.73
      9. group Id
        OG008
        lower Limit
        22.59
        upper Limit
        40.38
        value
        30.20
      10. group Id
        OG009
        lower Limit
        30.17
        upper Limit
        52.52
        value
        39.81
    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
      1
    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 total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.
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 number of subjects evaluable for this outcome measure and "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
Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)
type
SECONDARY
unit Of Measure
litre per hour (L/hr)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice