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NCT01524978 · OUTCOME

Duration of Response (DOR)

A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers · Source last updated 2017-11-20

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 3 years

What was measured

DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.

Analysis population: ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.

Groups in this outcome

Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib

Participants with NSCLC were treated with vemurafenib monotherapy.

Cohort 2: Ovarian Cancer - Vemurafenib

Participants with ovarian cancer were treated with vemurafenib monotherapy.

Cohort 3a: Colorectal Cancer - Vemurafenib

Participants with colorectal cancer were treated with vemurafenib monotherapy.

Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab

Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.

Cohort 4: Cholangiocarcinoma - Vemurafenib

Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.

Cohort 6: Multiple Myeloma - Vemurafenib

Participants with multiple myeloma were treated with vemurafenib monotherapy.

Cohort 7a: ECD/LCH - Vemurafenib

Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.

Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib

Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.

Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib

Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.

Cohort 7d: Early Stage Astrocytoma - Vemurafenib

Participants with early stage astrocytoma were treated with vemurafenib monotherapy.

Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib

Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib62
Cohort 2: Ovarian Cancer - Vemurafenib4
Cohort 3a: Colorectal Cancer - Vemurafenib10
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab27
Cohort 4: Cholangiocarcinoma - Vemurafenib9
Cohort 6: Multiple Myeloma - Vemurafenib9
Cohort 7a: ECD/LCH - Vemurafenib26
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib12
Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib12
Cohort 7d: Early Stage Astrocytoma - Vemurafenib9
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib28

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib7.16Not reported5.4918.43Not reported
Cohort 2: Ovarian Cancer - Vemurafenib8.16Not reported3.8812.45Not reported
Cohort 3a: Colorectal Cancer - VemurafenibNANot reportedNANAN/A=NE=not estimable, because of insufficient number of participants with events
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab6.54Not reported5.687.39Not reported
Cohort 4: Cholangiocarcinoma - Vemurafenib12.86Not reported3.5822.14Not reported
Cohort 6: Multiple Myeloma - VemurafenibNANot reportedNANAN/A=NE=not estimable, because of insufficient number of participants with events
Cohort 7a: ECD/LCH - VemurafenibNANot reportedNANAN/A=NE=not estimable, because of insufficient number of participants with events
Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib9.95Not reported8.3130.98Not reported
Cohort 7c: Advanced Stage Astrocytoma - VemurafenibNANot reported13.08NAN/A=NE=not estimable, because of insufficient number of participants with events
Cohort 7d: Early Stage Astrocytoma - Vemurafenib3.42Not reported2.407.49Not reported
Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib9.92Not reported3.4821.22Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.49
        upper Limit
        18.43
        value
        7.16
      2. group Id
        OG001
        lower Limit
        3.88
        upper Limit
        12.45
        value
        8.16
      3. comment
        N/A=NE=not estimable, because of insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. group Id
        OG003
        lower Limit
        5.68
        upper Limit
        7.39
        value
        6.54
      5. group Id
        OG004
        lower Limit
        3.58
        upper Limit
        22.14
        value
        12.86
      6. comment
        N/A=NE=not estimable, because of insufficient number of participants with events
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      7. comment
        N/A=NE=not estimable, because of insufficient number of participants with events
        group Id
        OG006
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      8. group Id
        OG007
        lower Limit
        8.31
        upper Limit
        30.98
        value
        9.95
      9. comment
        N/A=NE=not estimable, because of insufficient number of participants with events
        group Id
        OG008
        lower Limit
        13.08
        upper Limit
        NA
        value
        NA
      10. group Id
        OG009
        lower Limit
        2.40
        upper Limit
        7.49
        value
        3.42
      11. group Id
        OG010
        lower Limit
        3.48
        upper Limit
        21.22
        value
        9.92
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      27
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      26
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      12
    10. group Id
      OG009
      value
      9
    11. group Id
      OG010
      value
      28
    units
    Participants
description
DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of \>/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    OG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    OG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    OG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    OG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    OG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    OG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    OG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    OG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    OG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    OG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    OG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
param Type
MEDIAN
population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice