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NCT03973918 · OUTCOME

Progression Free Survival for 3 Treatment Cohorts

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

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

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 1: progression free survival

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 PXAs33.5Not reportedNot reportedNot reportedNot reported
pt 2: progression free survival

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 PXAs1.7Not reportedNot reportedNot reportedNot reported
pt 3: progression free survival

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 4: progression free survival

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 & GBM9.3Not reportedNot reportedNot reportedNot reported
pt 5: progression free survival

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 & GBM10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        33.5
    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 1: progression free survival
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        1.7
    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 2: progression free survival
  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 3: progression free survival
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9.3
    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 4: progression free survival
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    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 5: progression free survival
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status
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
Each row represents a specific patient. the number in that row equals the progression free survival for a specific patient, as there were only 5 patients Due to early termination, results are given per cohort per patient, as the data is meaningless otherwise due to small numbers
reporting Status
POSTED
time Frame
up to 3 years
title
Progression Free Survival for 3 Treatment Cohorts
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice