NCT03973918 · OUTCOME

Duration of Response - Complete and Partial

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG · Source last updated 2024-10-31

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

Measure: NUMBER
Unit: months
Interval / dispersion: Not reported
Time frame: up to 3 year

What was measured

Time from response to progression. Response is defined by RANO: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.

Analysis population: Each row represents the type of response. The number in that row equals the duration of response in months (mean) for all patients in cohort who had a response of the row title. There were 5 patients and only 3 patients had a response of CR or PR

Groups in this outcome

Treatment Cohort 1 AA & GBM

Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides

Treatment Cohort 2 Anaplastic PXAs

Treatment Cohort 3 Other Tumors

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
Treatment Cohort 1 AA & GBM	2
Treatment Cohort 2 Anaplastic PXAs	2
Treatment Cohort 3 Other Tumors	1

Reported measurements

Duration of Complete response (CR) from base line in months

Analysis denominator · Participants

Group	Source count
Treatment Cohort 1 AA & GBM	0
Treatment Cohort 2 Anaplastic PXAs	1
Treatment Cohort 3 Other Tumors	0

Values in months · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment Cohort 2 Anaplastic PXAs	34	Not reported	Not reported	Not reported	Not reported

Duration of Partial response (PR) from baseline months

Analysis denominator · Participants

Group	Source count
Treatment Cohort 1 AA & GBM	1
Treatment Cohort 2 Anaplastic PXAs	1
Treatment Cohort 3 Other Tumors	0

Values in months · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment Cohort 1 AA & GBM	8.5	Not reported	Not reported	Not reported	Not reported
Treatment Cohort 2 Anaplastic PXAs	8	Not reported	Not reported	Not reported	Not reported

Duration of Progressive Disease (PD)

Analysis denominator · Participants

Group	Source count
Treatment Cohort 1 AA & GBM	1
Treatment Cohort 2 Anaplastic PXAs	0
Treatment Cohort 3 Other Tumors	1

Values in months · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment Cohort 1 AA & GBM	2	Not reported	Not reported	Not reported	Not reported
Treatment Cohort 3 Other Tumors	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG001
value
34
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
units
Participants
title
Duration of Complete response (CR) from base line in months
categories
measurements
group Id
OG000
value
8.5
group Id
OG001
value
8
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
0
units
Participants
title
Duration of Partial response (PR) from baseline months
categories
measurements
group Id
OG000
value
2
group Id
OG002
value
4
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
units
Participants
title
Duration of Progressive Disease (PD)

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
units
Participants

description

groups

description
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
id
OG000
title
Treatment Cohort 1 AA & GBM
description
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
id
OG001
title
Treatment Cohort 2 Anaplastic PXAs
description
Encorafenib 450mg QD Binimetinib 45mg BID 28 day cycle Research Bloods Encorafenib: 450mg QD 28 day cycle Binimetinib: 45mg BID 28 day cycle Research Bloods: Baseline; pre-cycle 3; Pre-cycle 7; off Treatment Tumor Tissue: at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
id
OG002
title
Treatment Cohort 3 Other Tumors

param Type

NUMBER

population Description

Each row represents the type of response. The number in that row equals the duration of response in months (mean) for all patients in cohort who had a response of the row title. There were 5 patients and only 3 patients had a response of CR or PR

reporting Status

POSTED

time Frame

up to 3 year

title

Duration of Response - Complete and Partial

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice