NCT02639546 · OUTCOME

Apparent Clearance (CL/F) 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: GEOMETRIC_MEAN
Unit: L/hr
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21; pre-dose on Cycle 2 Day 1 (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, and within 4 hours prior to dosing on Day 1 of Cycle 2.

Analysis population: Please note that for this Outcome Measure, the Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing.

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

Group	Source 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 L/hr · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase I (Tablet) Cobimetinib (0.6 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Tablet) Cobimetinib (0.8 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Tablet) Cobimetinib (1 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Suspension) Cobimetinib (0.6 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Suspension) Cobimetinib (0.8 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Suspension) Cobimetinib (1 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase I (Suspension) Cobimetinib (1.33 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
Phase II (Suspension) Cobimetinib (1 mg/kg)	NA	NA	Not reported	Not reported	The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.

Complete source fields

classes

categories
measurements
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG000
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG001
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG002
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG003
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG004
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG005
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG006
spread
NA
value
NA
comment
The Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing which resulted in insufficient data to calculate CL/F.
group Id
OG007
spread
NA
value
NA

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
6
group Id
OG003
value
6
group Id
OG004
value
7
group Id
OG005
value
8
group Id
OG006
value
5
group Id
OG007
value
12
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

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)
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)
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)
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)
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)
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)
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)
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

GEOMETRIC_MEAN

population Description

Please note that for this Outcome Measure, the Apparent Clearance of Cobimetinib could not be calculated/estimated as PK samples were collected only up to 24hr post dosing.

reporting Status

POSTED

time Frame

Pre-dose, 2, 4, 6, and 24 hours post-dose on Cycle 1 Days 1 and 21; pre-dose on Cycle 2 Day 1 (pre-dose=within 4 hours prior to dose; cycle length=28 days)

title

Apparent Clearance (CL/F) of Cobimetinib

type

SECONDARY

unit Of Measure

L/hr

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

Preserved source evidence · Not medical advice