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NCT03973918 · OUTCOME

Overall Survival

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 years

What was measured

overall survival in months. Specific survival for each patient due to early termination

Analysis population: Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers Each row represents a specific patient. the number in that row equals the overall survival for a specific patient, as there were only 5 patients

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

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 3 Other Tumors

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM2
Treatment Cohort 2 Anaplastic PXAs2
Treatment Cohort 3 Other Tumors1

Reported measurements

pt number 1

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM0
Treatment Cohort 2 Anaplastic PXAs1
Treatment Cohort 3 Other Tumors0
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 2 Anaplastic PXAs33.9Not reportedNot reportedNot reportedNot reported
pt number 2

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM0
Treatment Cohort 2 Anaplastic PXAs1
Treatment Cohort 3 Other Tumors0
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 2 Anaplastic PXAs5.1Not reportedNot reportedNot reportedNot reported
pt number 3

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM0
Treatment Cohort 2 Anaplastic PXAs0
Treatment Cohort 3 Other Tumors1
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 3 Other Tumors4.2Not reportedNot reportedNot reportedNot reported
pt number 4

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM1
Treatment Cohort 2 Anaplastic PXAs0
Treatment Cohort 3 Other Tumors0
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM10.7Not reportedNot reportedNot reportedNot reported
pt number 5

Analysis denominator · Participants

GroupSource count
Treatment Cohort 1 AA & GBM1
Treatment Cohort 2 Anaplastic PXAs0
Treatment Cohort 3 Other Tumors0
Values in months · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Cohort 1 AA & GBM12.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        33.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    pt number 1
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        5.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    pt number 2
  3. categories
    1. measurements
      1. group Id
        OG002
        value
        4.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    pt number 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    pt number 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        12.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    pt number 5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    units
    Participants
description
overall survival in months. Specific survival for each patient due to early termination
groups
  1. 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
  2. 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
  3. 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
Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers Each row represents a specific patient. the number in that row equals the overall survival for a specific patient, as there were only 5 patients
reporting Status
POSTED
time Frame
up to 3 years
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice