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NCT02639546 · OUTCOME

Time to Cmax (Tmax) of Cobimetinib

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors · Source last updated 2022-09-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
hr
Interval / dispersion
Full Range
Time frame
Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days)

What was measured

Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Tmax.

Analysis population: The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.

Groups in this outcome

Phase I (Tablet) Cobimetinib (0.6 mg/kg)

Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Tablet) Cobimetinib (0.8 mg/kg)

Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Tablet) Cobimetinib (1 mg/kg)

Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Suspension) Cobimetinib (0.6 mg/kg)

Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Suspension) Cobimetinib (0.8 mg/kg)

Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Suspension) Cobimetinib (1 mg/kg)

Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase I (Suspension) Cobimetinib (1.33 mg/kg)

Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Phase II (Suspension) Cobimetinib (1 mg/kg)

Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I (Tablet) Cobimetinib (0.6 mg/kg)6
Phase I (Tablet) Cobimetinib (0.8 mg/kg)6
Phase I (Tablet) Cobimetinib (1 mg/kg)6
Phase I (Suspension) Cobimetinib (0.6 mg/kg)6
Phase I (Suspension) Cobimetinib (0.8 mg/kg)7
Phase I (Suspension) Cobimetinib (1 mg/kg)8
Phase I (Suspension) Cobimetinib (1.33 mg/kg)5
Phase II (Suspension) Cobimetinib (1 mg/kg)12

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Phase I (Tablet) Cobimetinib (0.6 mg/kg)6
Phase I (Tablet) Cobimetinib (0.8 mg/kg)5
Phase I (Tablet) Cobimetinib (1 mg/kg)6
Phase I (Suspension) Cobimetinib (0.6 mg/kg)6
Phase I (Suspension) Cobimetinib (0.8 mg/kg)7
Phase I (Suspension) Cobimetinib (1 mg/kg)8
Phase I (Suspension) Cobimetinib (1.33 mg/kg)4
Phase II (Suspension) Cobimetinib (1 mg/kg)9
Values in hr · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I (Tablet) Cobimetinib (0.6 mg/kg)4Not reported26Not reported
Phase I (Tablet) Cobimetinib (0.8 mg/kg)2Not reported26Not reported
Phase I (Tablet) Cobimetinib (1 mg/kg)3Not reported24Not reported
Phase I (Suspension) Cobimetinib (0.6 mg/kg)4Not reported26Not reported
Phase I (Suspension) Cobimetinib (0.8 mg/kg)4Not reported26Not reported
Phase I (Suspension) Cobimetinib (1 mg/kg)2Not reported24Not reported
Phase I (Suspension) Cobimetinib (1.33 mg/kg)5Not reported26Not reported
Phase II (Suspension) Cobimetinib (1 mg/kg)4Not reported26Not reported
Cycle 1 Day 21

Analysis denominator · Participants

GroupSource count
Phase I (Tablet) Cobimetinib (0.6 mg/kg)5
Phase I (Tablet) Cobimetinib (0.8 mg/kg)5
Phase I (Tablet) Cobimetinib (1 mg/kg)5
Phase I (Suspension) Cobimetinib (0.6 mg/kg)6
Phase I (Suspension) Cobimetinib (0.8 mg/kg)6
Phase I (Suspension) Cobimetinib (1 mg/kg)8
Phase I (Suspension) Cobimetinib (1.33 mg/kg)2
Phase II (Suspension) Cobimetinib (1 mg/kg)9
Values in hr · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I (Tablet) Cobimetinib (0.6 mg/kg)4Not reported26Not reported
Phase I (Tablet) Cobimetinib (0.8 mg/kg)4Not reported26Not reported
Phase I (Tablet) Cobimetinib (1 mg/kg)2Not reported24Not reported
Phase I (Suspension) Cobimetinib (0.6 mg/kg)4Not reported26Not reported
Phase I (Suspension) Cobimetinib (0.8 mg/kg)2Not reported24Not reported
Phase I (Suspension) Cobimetinib (1 mg/kg)3Not reported26Not reported
Phase I (Suspension) Cobimetinib (1.33 mg/kg)4Not reported44Not reported
Phase II (Suspension) Cobimetinib (1 mg/kg)2Not reported26Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        6
        value
        2
      3. group Id
        OG002
        lower Limit
        2
        upper Limit
        4
        value
        3
      4. group Id
        OG003
        lower Limit
        2
        upper Limit
        6
        value
        4
      5. group Id
        OG004
        lower Limit
        2
        upper Limit
        6
        value
        4
      6. group Id
        OG005
        lower Limit
        2
        upper Limit
        4
        value
        2
      7. group Id
        OG006
        lower Limit
        2
        upper Limit
        6
        value
        5
      8. group Id
        OG007
        lower Limit
        2
        upper Limit
        6
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        9
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        6
        value
        4
      3. group Id
        OG002
        lower Limit
        2
        upper Limit
        4
        value
        2
      4. group Id
        OG003
        lower Limit
        2
        upper Limit
        6
        value
        4
      5. group Id
        OG004
        lower Limit
        2
        upper Limit
        4
        value
        2
      6. group Id
        OG005
        lower Limit
        2
        upper Limit
        6
        value
        3
      7. group Id
        OG006
        lower Limit
        4
        upper Limit
        4
        value
        4
      8. group Id
        OG007
        lower Limit
        2
        upper Limit
        6
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        9
      units
      Participants
    title
    Cycle 1 Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      12
    units
    Participants
description
Plasma samples for determination of Cobimetinib concentration were collected prior to dosing and at 2, 4, 6 and 24 hours after dosing on Days 1 and 21 of Cycle 1. The sampling will allow determination of Tmax.
dispersion Type
Full Range
groups
  1. description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG000
    title
    Phase I (Tablet) Cobimetinib (0.6 mg/kg)
  2. description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG001
    title
    Phase I (Tablet) Cobimetinib (0.8 mg/kg)
  3. description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG002
    title
    Phase I (Tablet) Cobimetinib (1 mg/kg)
  4. description
    Dose-Escalation: Participants received 0.6 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG003
    title
    Phase I (Suspension) Cobimetinib (0.6 mg/kg)
  5. description
    Dose-Escalation: Participants received 0.8 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG004
    title
    Phase I (Suspension) Cobimetinib (0.8 mg/kg)
  6. description
    Dose-Escalation: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG005
    title
    Phase I (Suspension) Cobimetinib (1 mg/kg)
  7. description
    Dose-Escalation: Participants received 1.33 milligrams per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG006
    title
    Phase I (Suspension) Cobimetinib (1.33 mg/kg)
  8. description
    Dose-Expansion: Participants received 1 milligram per kilogram (mg/kg) cobimetinib orally once daily on Days 1 to 21 of each 28-day treatment cycle.
    id
    OG007
    title
    Phase II (Suspension) Cobimetinib (1 mg/kg)
param Type
MEDIAN
population Description
The PK population was defined as all participants who received at least 1 dose of Cobimetinib and had evaluable PK data. Only participants for whom data were collected are included in the analysis.
reporting Status
POSTED
time Frame
Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21 (pre-dose=within 4 hours prior to dose; cycle length=28 days)
title
Time to Cmax (Tmax) of Cobimetinib
type
SECONDARY
unit Of Measure
hr

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice