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NCT01524978 · OUTCOME

Time to Response

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

Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.

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) - Vemurafenib7.26Not reported3.68NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 2: Ovarian Cancer - VemurafenibNANot reported1.64NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 3a: Colorectal Cancer - VemurafenibNANot reportedNANAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 3b: Colorectal Cancer - Vemurafenib + CetuximabNANot reportedNANAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 4: Cholangiocarcinoma - VemurafenibNANot reported3.52NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 6: Multiple Myeloma - Vemurafenib5.75Not reportedNANAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 7a: ECD/LCH - Vemurafenib5.49Not reported3.6813.73Not reported
Cohort 7b: Anaplastic Thyroid Cancer - VemurafenibNANot reported1.68NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 7c: Advanced Stage Astrocytoma - VemurafenibNANot reported1.74NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 7d: Early Stage Astrocytoma - VemurafenibNANot reported2.33NAN/A=NE=not estimable due to insufficient number of participants with events
Cohort 7: Other BRAF V600-positive Tumors - VemurafenibNANot reported3.68NAN/A=NE=not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        3.68
        upper Limit
        NA
        value
        7.26
      2. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        1.64
        upper Limit
        NA
        value
        NA
      3. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      5. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG004
        lower Limit
        3.52
        upper Limit
        NA
        value
        NA
      6. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        5.75
      7. group Id
        OG006
        lower Limit
        3.68
        upper Limit
        13.73
        value
        5.49
      8. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG007
        lower Limit
        1.68
        upper Limit
        NA
        value
        NA
      9. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG008
        lower Limit
        1.74
        upper Limit
        NA
        value
        NA
      10. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG009
        lower Limit
        2.33
        upper Limit
        NA
        value
        NA
      11. comment
        N/A=NE=not estimable due to insufficient number of participants with events
        group Id
        OG010
        lower Limit
        3.68
        upper Limit
        NA
        value
        NA
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
Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \</= 5% plasma cells in bone marrow; PR: \>/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>/= 90% or to \< 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.
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
Time to Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice