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NCT02639546 · OUTCOME

Percentage of Participants With Dose-Limiting Toxicities (DLTs)

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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)

What was measured

Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib.

Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug.

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

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I (Tablet) Cobimetinib (0.6 mg/kg)0Not reportedNot reportedNot reportedNot reported
Phase I (Tablet) Cobimetinib (0.8 mg/kg)0Not reportedNot reportedNot reportedNot reported
Phase I (Tablet) Cobimetinib (1 mg/kg)33.3Not reportedNot reportedNot reportedNot reported
Phase I (Suspension) Cobimetinib (0.6 mg/kg)16.7Not reportedNot reportedNot reportedNot reported
Phase I (Suspension) Cobimetinib (0.8 mg/kg)0Not reportedNot reportedNot reportedNot reported
Phase I (Suspension) Cobimetinib (1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Phase I (Suspension) Cobimetinib (1.33 mg/kg)60.0Not reportedNot reportedNot reportedNot reported
Phase II (Suspension) Cobimetinib (1 mg/kg)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        33.3
      4. group Id
        OG003
        value
        16.7
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        60.0
      8. group Id
        OG007
        value
        0
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
Dose-Limiting Toxicities (DLTs) were defined as cobimetinib-related adverse events occurring within the first 28 days of each administration of cobimetinib.
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
NUMBER
population Description
The safety evaluable population was defined as all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Baseline up until 30 days after the last dose of study drug (up to 5 years, 2 months)
title
Percentage of Participants With Dose-Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice