NCT02639546 · OUTCOME

Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) 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 MTD/MAD 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 (Tablet) Population

Participants received Cobimetinib (Tablet) formulation

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

Group	Source count
Cobimetinib (Tablet) Population	18
Cobimetinib (Suspension) Population	38

Reported measurements

Source class 1

Values in mg/kg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cobimetinib (Tablet) Population	0.8	Not reported	Not reported	Not reported	Not reported
Cobimetinib (Suspension) Population	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.8
group Id
OG001
value
1

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
38
units
Participants

description

A prior dose level was defined as an MTD/MAD 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

description
Participants received Cobimetinib (Tablet) formulation
id
OG000
title
Cobimetinib (Tablet) Population
description
Participants received Cobimetinib (Suspension) formulation
id
OG001
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

Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Cobimetinib

type

PRIMARY

unit Of Measure

mg/kg

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

Preserved source evidence · Not medical advice