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NCT02639546 · OUTCOME

Recommended Phase II Dose (RP2D) 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
NUMBER
Unit
mg/kg
Interval / dispersion
Not reported
Time frame
Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)

What was measured

A prior dose level was defined as an RP2D if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs).

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

Groups in this outcome

Cobimetinib (Suspension) Population

Participants received Cobimetinib (Suspension) formulation

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

Analysis denominator · Participants

GroupSource count
Cobimetinib (Suspension) Population38

Reported measurements

Source class 1
Values in mg/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cobimetinib (Suspension) Population1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
A prior dose level was defined as an RP2D if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs).
groups
  1. description
    Participants received Cobimetinib (Suspension) formulation
    id
    OG000
    title
    Cobimetinib (Suspension) Population
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
Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length=28 days)
title
Recommended Phase II Dose (RP2D) of Cobimetinib
type
SECONDARY
unit Of Measure
mg/kg

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

Preserved source evidence · Not medical advice