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NCT02928224 · OUTCOME

(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

What was measured

FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants \& participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled \& combined to form functional well-being subscale score (range 0-28). High score represents better QoL.

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

Groups in this outcome

Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

Phase 3:Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Phase 3:Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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 3: Triplet Arm	224
Phase 3:Doublet Arm	220
Phase 3:Control Arm	221

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	211
Phase 3:Doublet Arm	199
Phase 3:Control Arm	200

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	16.3	6.22	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	16.2	5.9	Not reported	Not reported	Not reported
Phase 3:Control Arm	16.8	6.07	Not reported	Not reported	Not reported

Change at Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	142
Phase 3:Doublet Arm	130
Phase 3:Control Arm	117

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.2	3.36	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.9	4.06	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.4	3.32	Not reported	Not reported	Not reported

Change at Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	183
Phase 3:Doublet Arm	176
Phase 3:Control Arm	123

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.3	4.28	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.6	5.08	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.9	4.48	Not reported	Not reported	Not reported

Change at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	148
Phase 3:Doublet Arm	137
Phase 3:Control Arm	50

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.2	5.15	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.2	5.23	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.7	5.03	Not reported	Not reported	Not reported

Change at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	119
Phase 3:Doublet Arm	105
Phase 3:Control Arm	37

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.4	4.53	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.1	4.66	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.8	6.48	Not reported	Not reported	Not reported

Change at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	100
Phase 3:Doublet Arm	81
Phase 3:Control Arm	26

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.7	6.4	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.2	4.5	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.6	4.58	Not reported	Not reported	Not reported

Change at Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	68
Phase 3:Doublet Arm	58
Phase 3:Control Arm	13

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.7	6.05	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	0.6	4.56	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.9	5.3	Not reported	Not reported	Not reported

Change at Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	47
Phase 3:Doublet Arm	49
Phase 3:Control Arm	10

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.5	5.85	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.1	4.70	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.5	5.41	Not reported	Not reported	Not reported

Change at Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	40
Phase 3:Doublet Arm	39
Phase 3:Control Arm	8

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.9	6.35	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	0.2	4.24	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.1	4.97	Not reported	Not reported	Not reported

Change at Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	32
Phase 3:Doublet Arm	30
Phase 3:Control Arm	7

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.9	4.32	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.8	3.74	Not reported	Not reported	Not reported
Phase 3:Control Arm	-2.6	2.30	Not reported	Not reported	Not reported

Change at Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	22
Phase 3:Doublet Arm	24
Phase 3:Control Arm	4

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.7	4.76	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.3	3.59	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.5	4.36	Not reported	Not reported	Not reported

Change at Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	17
Phase 3:Doublet Arm	19
Phase 3:Control Arm	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.5	4.47	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.5	4.65	Not reported	Not reported	Not reported
Phase 3:Control Arm	-4.5	7.78	Not reported	Not reported	Not reported

Change at Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	14
Phase 3:Doublet Arm	18
Phase 3:Control Arm	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.5	4.93	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.1	4.61	Not reported	Not reported	Not reported
Phase 3:Control Arm	-4.5	9.19	Not reported	Not reported	Not reported

Change at Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	9
Phase 3:Doublet Arm	13
Phase 3:Control Arm	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.0	6.76	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-3.2	5.34	Not reported	Not reported	Not reported
Phase 3:Control Arm	-8.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	7
Phase 3:Doublet Arm	7
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.4	5.22	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-4.0	5.74	Not reported	Not reported	Not reported

Change at Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	7
Phase 3:Doublet Arm	6
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.3	6.85	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.5	4.72	Not reported	Not reported	Not reported

Change at Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	5
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-4.2	4.02	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.7	0.58	Not reported	Not reported	Not reported

Change at Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	3
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-6.7	5.51	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.7	4.51	Not reported	Not reported	Not reported

Change at Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-5.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-3.0	4.36	Not reported	Not reported	Not reported

Change at Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	2
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-7.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-6.0	0.00	Not reported	Not reported	Not reported

Change at Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-6.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-5.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-9.0	Not reported	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-5.0	Not reported	Not reported	Not reported	Not reported

Change at Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	-12.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 23 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	-9.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at End of Treatment

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	74
Phase 3:Doublet Arm	73
Phase 3:Control Arm	79

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.4	4.84	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-2.2	5.14	Not reported	Not reported	Not reported
Phase 3:Control Arm	-3.1	6.06	Not reported	Not reported	Not reported

Change at 30 Day Follow Up

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	24
Phase 3:Doublet Arm	16
Phase 3:Control Arm	21

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-3.5	6.44	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.8	5.42	Not reported	Not reported	Not reported
Phase 3:Control Arm	-4.2	6.41	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
6.22
value
16.3
group Id
OG001
spread
5.9
value
16.2
group Id
OG002
spread
6.07
value
16.8
denoms
counts
group Id
OG000
value
211
group Id
OG001
value
199
group Id
OG002
value
200
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
3.36
value
-0.2
group Id
OG001
spread
4.06
value
-0.9
group Id
OG002
spread
3.32
value
-1.4
denoms
counts
group Id
OG000
value
142
group Id
OG001
value
130
group Id
OG002
value
117
units
Participants
title
Change at Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
4.28
value
-0.3
group Id
OG001
spread
5.08
value
-0.6
group Id
OG002
spread
4.48
value
-0.9
denoms
counts
group Id
OG000
value
183
group Id
OG001
value
176
group Id
OG002
value
123
units
Participants
title
Change at Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
5.15
value
-0.2
group Id
OG001
spread
5.23
value
-0.2
group Id
OG002
spread
5.03
value
-0.7
denoms
counts
group Id
OG000
value
148
group Id
OG001
value
137
group Id
OG002
value
50
units
Participants
title
Change at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
4.53
value
0.4
group Id
OG001
spread
4.66
value
-0.1
group Id
OG002
spread
6.48
value
-1.8
denoms
counts
group Id
OG000
value
119
group Id
OG001
value
105
group Id
OG002
value
37
units
Participants
title
Change at Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
6.4
value
0.7
group Id
OG001
spread
4.5
value
-0.2
group Id
OG002
spread
4.58
value
-1.6
denoms
counts
group Id
OG000
value
100
group Id
OG001
value
81
group Id
OG002
value
26
units
Participants
title
Change at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
6.05
value
0.7
group Id
OG001
spread
4.56
value
0.6
group Id
OG002
spread
5.3
value
-1.9
denoms
counts
group Id
OG000
value
68
group Id
OG001
value
58
group Id
OG002
value
13
units
Participants
title
Change at Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
5.85
value
0.5
group Id
OG001
spread
4.70
value
-0.1
group Id
OG002
spread
5.41
value
-0.5
denoms
counts
group Id
OG000
value
47
group Id
OG001
value
49
group Id
OG002
value
10
units
Participants
title
Change at Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
6.35
value
0.9
group Id
OG001
spread
4.24
value
0.2
group Id
OG002
spread
4.97
value
-2.1
denoms
counts
group Id
OG000
value
40
group Id
OG001
value
39
group Id
OG002
value
8
units
Participants
title
Change at Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
4.32
value
-1.9
group Id
OG001
spread
3.74
value
-0.8
group Id
OG002
spread
2.30
value
-2.6
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
30
group Id
OG002
value
7
units
Participants
title
Change at Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
4.76
value
-1.7
group Id
OG001
spread
3.59
value
-1.3
group Id
OG002
spread
4.36
value
0.5
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
24
group Id
OG002
value
4
units
Participants
title
Change at Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
4.47
value
-1.5
group Id
OG001
spread
4.65
value
-0.5
group Id
OG002
spread
7.78
value
-4.5
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
19
group Id
OG002
value
2
units
Participants
title
Change at Cycle 11 Day 1

denoms

counts
group Id
OG000
value
224
group Id
OG001
value
220
group Id
OG002
value
221
units
Participants

description

FACT-C= Functional Assessment of Chronic Illness Therapy (FACIT), which assessed HRQoL of cancer participants \& participants with other chronic illnesses. It consists of total 36 items (27 items of general version of FACT-C and disease-specific subscale containing 9 CRC-specific items), summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range:0-28, emotional well-being (6 items) range: 0-24, colorectal cancer subscale (9 items) range: 0-36; higher subscale score= better QoL. All single-item measures range: 0= 'Not at all' to 4= 'Very much'. Table summarizes functional well-being subscale, individual questions are linearly scaled \& combined to form functional well-being subscale score (range 0-28). High score represents better QoL.

dispersion Type

Standard Deviation

groups

description
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
id
OG000
title
Phase 3: Triplet Arm
description
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
id
OG001
title
Phase 3:Doublet Arm
description
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
id
OG002
title
Phase 3:Control Arm

param Type

MEAN

population Description

The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

reporting Status

POSTED

time Frame

Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

title

(Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Independent clinical review pending · Not medical advice