NCT02457793 · OUTCOME

Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors · Source last updated 2018-11-20

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

Measure: GEOMETRIC_MEAN
Unit: ng x hr/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 0 to 24 hours post-dose (Up to Day 22)

Analysis population: Data are reported for evaluable participants.

Groups in this outcome

COB 80 mg + GDC 300 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.

COB 20 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 40 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 80 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

COB 80 mg + GDC 400 mg

Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.

COB 100 mg + GDC 200 mg

Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.

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
COB 80 mg + GDC 300 mg	1
COB 20 mg + GDC 200 mg	5
COB 40 mg + GDC 200 mg	3
COB 80 mg + GDC 200 mg	5
COB 80 mg + GDC 400 mg	4
COB 100 mg + GDC 200 mg	6

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
COB 80 mg + GDC 300 mg	0
COB 20 mg + GDC 200 mg	5
COB 40 mg + GDC 200 mg	3
COB 80 mg + GDC 200 mg	5
COB 80 mg + GDC 400 mg	4
COB 100 mg + GDC 200 mg	6

Values in ng x hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
COB 20 mg + GDC 200 mg	501	121.0	Not reported	Not reported	Not reported
COB 40 mg + GDC 200 mg	1020	33.9	Not reported	Not reported	Not reported
COB 80 mg + GDC 200 mg	4420	25.5	Not reported	Not reported	Not reported
COB 80 mg + GDC 400 mg	2460	50.9	Not reported	Not reported	Not reported
COB 100 mg + GDC 200 mg	4060	74.3	Not reported	Not reported	Not reported

Steady State

Analysis denominator · Participants

Group	Source count
COB 80 mg + GDC 300 mg	1
COB 20 mg + GDC 200 mg	2
COB 40 mg + GDC 200 mg	1
COB 80 mg + GDC 200 mg	3
COB 80 mg + GDC 400 mg	1
COB 100 mg + GDC 200 mg	1

Values in ng x hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
COB 80 mg + GDC 300 mg	908	Not reported	Not reported	Not reported	Not reported
COB 20 mg + GDC 200 mg	508	255.0	Not reported	Not reported	Not reported
COB 40 mg + GDC 200 mg	2460	Not reported	Not reported	Not reported	Not reported
COB 80 mg + GDC 200 mg	4320	37.4	Not reported	Not reported	Not reported
COB 80 mg + GDC 400 mg	3410	Not reported	Not reported	Not reported	Not reported
COB 100 mg + GDC 200 mg	4070	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG001
spread
121.0
value
501
group Id
OG002
spread
33.9
value
1020
group Id
OG003
spread
25.5
value
4420
group Id
OG004
spread
50.9
value
2460
group Id
OG005
spread
74.3
value
4060
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants
title
Day 1
categories
measurements
group Id
OG000
value
908
group Id
OG001
spread
255.0
value
508
group Id
OG002
value
2460
group Id
OG003
spread
37.4
value
4320
group Id
OG004
value
3410
group Id
OG005
value
4070
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
1
units
Participants
title
Steady State

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
4
group Id
OG005
value
6
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 300 mg for 21 consecutive days, followed by 7 days off.
id
OG000
title
COB 80 mg + GDC 300 mg
description
Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG001
title
COB 20 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG002
title
COB 40 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG003
title
COB 80 mg + GDC 200 mg
description
Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
id
OG004
title
COB 80 mg + GDC 400 mg
description
Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
id
OG005
title
COB 100 mg + GDC 200 mg

param Type

GEOMETRIC_MEAN

population Description

Data are reported for evaluable participants.

reporting Status

POSTED

time Frame

0 to 24 hours post-dose (Up to Day 22)

title

Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib

type

SECONDARY

unit Of Measure

ng x hr/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice