NCT02457793 · OUTCOME

Maximum Serum Concentration (Cmax) for GDC-0994

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: micromoles
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 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 micromoles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
COB 20 mg + GDC 200 mg	2.51	54.6	Not reported	Not reported	Not reported
COB 40 mg + GDC 200 mg	2.08	68.4	Not reported	Not reported	Not reported
COB 80 mg + GDC 200 mg	2.02	109.0	Not reported	Not reported	Not reported
COB 80 mg + GDC 400 mg	2.42	33.6	Not reported	Not reported	Not reported
COB 100 mg + GDC 200 mg	2.56	77.8	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	2

Values in micromoles · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
COB 80 mg + GDC 300 mg	2.56	Not reported	Not reported	Not reported	Not reported
COB 20 mg + GDC 200 mg	1.80	74.2	Not reported	Not reported	Not reported
COB 40 mg + GDC 200 mg	2.01	0.0	Not reported	Not reported	Not reported
COB 80 mg + GDC 200 mg	2.26	23.1	Not reported	Not reported	Not reported
COB 80 mg + GDC 400 mg	2.09	0.0	Not reported	Not reported	Not reported
COB 100 mg + GDC 200 mg	2.36	28.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG001
spread
54.6
value
2.51
group Id
OG002
spread
68.4
value
2.08
group Id
OG003
spread
109.0
value
2.02
group Id
OG004
spread
33.6
value
2.42
group Id
OG005
spread
77.8
value
2.56
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
2.56
group Id
OG001
spread
74.2
value
1.80
group Id
OG002
spread
0.0
value
2.01
group Id
OG003
spread
23.1
value
2.26
group Id
OG004
spread
0.0
value
2.09
group Id
OG005
spread
28.2
value
2.36
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
2
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

Up to Day 22

title

Maximum Serum Concentration (Cmax) for GDC-0994

type

SECONDARY

unit Of Measure

micromoles

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Preserved source evidence · Not medical advice