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A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524978
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma, Neoplasms
Interventions Drug: cetuximab
Drug: vemurafenib
Enrollment 208
Recruitment Details  
Pre-assignment Details One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description Participants with NSCLC were treated with vemurafenib monotherapy. Participants with ovarian cancer were treated with vemurafenib monotherapy. Participants with colorectal cancer were treated with vemurafenib monotherapy. Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. Participants with multiple myeloma were treated with vemurafenib monotherapy. Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. Participants with early stage astrocytoma were treated with vemurafenib monotherapy. Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Period Title: Overall Study
Started 62 4 10 27 9 9 26 12 12 9 28
Completed 0 0 0 0 0 0 0 0 0 0 0
Not Completed 62 4 10 27 9 9 26 12 12 9 28
Reason Not Completed
Other             16             2             1             2             1             3             17             1             2             2             5
Withdrawal by Subject             12             0             1             1             3             1             6             2             4             0             5
Lost to Follow-up             0             0             3             0             1             1             2             0             1             1             1
Death             34             2             5             24             4             4             1             9             5             6             17
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib Total
Hide Arm/Group Description Participants with NSCLC were treated with vemurafenib monotherapy. Participants with ovarian cancer were treated with vemurafenib monotherapy. Participants with colorectal cancer were treated with vemurafenib monotherapy. Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. Participants with cholangiocarcinoma were treated with vemurafenib monotherapy. Participants with multiple myeloma were treated with vemurafenib monotherapy. Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy. Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy. Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy. Participants with early stage astrocytoma were treated with vemurafenib monotherapy. Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy. Total of all reporting groups
Overall Number of Baseline Participants 62 4 10 27 9 9 26 12 12 9 28 208
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 4 participants 10 participants 27 participants 9 participants 9 participants 26 participants 12 participants 12 participants 9 participants 28 participants 208 participants
65.4  (10.2) 45.8  (5.3) 57.3  (5.4) 64.3  (8.8) 53.2  (9.7) 62.1  (4.3) 60.8  (13.3) 66.8  (9.2) 41.6  (12.2) 34.3  (20.7) 53.7  (17.5) 59.0  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 4 participants 10 participants 27 participants 9 participants 9 participants 26 participants 12 participants 12 participants 9 participants 28 participants 208 participants
Female
27
  43.5%
4
 100.0%
5
  50.0%
18
  66.7%
5
  55.6%
3
  33.3%
14
  53.8%
3
  25.0%
8
  66.7%
9
 100.0%
15
  53.6%
111
  53.4%
Male
35
  56.5%
0
   0.0%
5
  50.0%
9
  33.3%
4
  44.4%
6
  66.7%
12
  46.2%
9
  75.0%
4
  33.3%
0
   0.0%
13
  46.4%
97
  46.6%
1.Primary Outcome
Title Confirmed Best Overall Response Rate (BORR)
Hide Description Confirmed BORR: percentage of participants with an objective response (OR) (complete response [CR], partial response [PR], stringent CR [sCR] or very good PR [VGPR]) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, 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 free light chain (FLC) ratio and no clonal cells in bone marrow.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.1
(25.16 to 50.31)
50.0
(6.76 to 93.24)
0
(0.00 to 30.85)
7.4
(0.91 to 24.29)
22.2
(2.81 to 60.01)
22.2
(2.81 to 60.01)
61.5
(40.57 to 79.77)
25.0
(5.49 to 57.19)
16.7
(2.09 to 48.41)
33.3
(7.49 to 70.07)
17.9
(6.06 to 36.89)
2.Secondary Outcome
Title Percentage of Participants With Confirmed Clinical Benefit
Hide Description Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: >/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, 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; SD: not meeting criteria for CR, VGPR, PR or PD.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.4
(35.50 to 61.44)
50.0
(6.76 to 93.24)
0 [1] 
(NA to NA)
18.5
(6.30 to 38.08)
44.4
(13.70 to 78.80)
22.2
(2.81 to 60.01)
76.9
(56.35 to 91.03)
25.0
(5.49 to 57.19)
33.3
(9.92 to 65.11)
44.4
(13.70 to 78.80)
17.9
(6.06 to 36.89)
[1]
N/A=NE=not estimable, because of insufficient number of participants with events
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0
(0.00 to 5.78)
0
(0.00 to 60.24)
0
(0.00 to 30.85)
0
(0.00 to 12.77)
0
(0.00 to 33.63)
0
(0.00 to 33.63)
7.7
(0.95 to 25.13)
8.3
(0.21 to 38.48)
8.3
(0.21 to 38.48)
0
(0.00 to 33.63)
3.6
(0.09 to 18.35)
PR
37.1
(25.16 to 50.31)
50.0
(6.76 to 93.24)
0
(0.00 to 30.85)
7.4
(0.91 to 24.29)
22.2
(2.81 to 60.01)
11.1
(0.28 to 48.25)
53.8
(33.37 to 73.41)
16.7
(2.09 to 48.41)
8.3
(0.21 to 38.48)
33.3
(7.49 to 70.07)
14.3
(4.03 to 32.67)
VGPR
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
11.1
(0.28 to 48.25)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
sCR
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
0
(0.00 to 33.63)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
N/A= VGPR data only collected in multiple myeloma cohort
[2]
N/A= sCR data only collected in multiple myeloma cohort
4.Secondary Outcome
Title Duration of Response (DOR)
Hide 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Median (95% Confidence Interval)
Unit of Measure: months
7.16
(5.49 to 18.43)
8.16
(3.88 to 12.45)
NA [1] 
(NA to NA)
6.54
(5.68 to 7.39)
12.86
(3.58 to 22.14)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
9.95
(8.31 to 30.98)
NA [1] 
(13.08 to NA)
3.42
(2.40 to 7.49)
9.92
(3.48 to 21.22)
[1]
N/A=NE=not estimable, because of insufficient number of participants with events
5.Secondary Outcome
Title Time to Response
Hide 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Median (95% Confidence Interval)
Unit of Measure: months
7.26 [1] 
(3.68 to NA)
NA [1] 
(1.64 to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(3.52 to NA)
5.75 [1] 
(NA to NA)
5.49
(3.68 to 13.73)
NA [1] 
(1.68 to NA)
NA [1] 
(1.74 to NA)
NA [1] 
(2.33 to NA)
NA [1] 
(3.68 to NA)
[1]
N/A=NE=not estimable due to insufficient number of participants with events
6.Secondary Outcome
Title Time to Tumor Progression (TTP)
Hide Description TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Median (95% Confidence Interval)
Unit of Measure: months
7.33
(5.29 to 9.66)
6.44
(1.87 to 14.29)
3.88
(1.84 to 5.52)
3.68
(3.45 to 5.39)
3.02
(1.64 to 9.00)
4.63 [1] 
(2.89 to NA)
NA [1] 
(NA to NA)
2.83
(1.77 to 5.49)
5.62
(1.81 to 14.85)
5.36
(3.02 to 9.10)
3.65
(1.68 to 5.75)
[1]
N/A=NE=not estimable due to insufficient number of participants with events
7.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. 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 criteria: 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.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Median (95% Confidence Interval)
Unit of Measure: months
6.51
(5.16 to 8.97)
6.44
(1.87 to 14.29)
3.88
(1.84 to 5.52)
3.68
(1.81 to 5.39)
3.02
(1.64 to 9.00)
4.63 [1] 
(2.89 to NA)
NA [1] 
(NA to NA)
2.83
(1.77 to 5.49)
9.59
(1.81 to 14.78)
5.26
(3.02 to 5.72)
3.12
(1.64 to 5.55)
[1]
N/A=NE=not estimable due to insufficient number of participants with events
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as time between the first day of study treatment and date of death of any cause.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Median (95% Confidence Interval)
Unit of Measure: months
15.38
(9.56 to 22.77)
NA [1] 
(2.56 to NA)
9.30
(7.82 to 12.88)
7.16
(5.49 to 11.73)
17.94 [1] 
(11.20 to NA)
24.54 [1] 
(4.96 to NA)
NA [1] 
(NA to NA)
5.88
(2.17 to 16.79)
40.11
(9.59 to 40.11)
12.75 [1] 
(6.70 to NA)
11.56
(3.71 to 28.16)
[1]
N/A=NE=not estimable due to insufficient number of participants with events
9.Secondary Outcome
Title Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
Hide Description Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from Cohort 3b who received at least one dose of study medication.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 0 0 0 14 0 0 0 0 0 0 0
Measure Type: Number
Unit of Measure: milligrams (mg)
vemurafenib 960
cetuximab 400
10.Secondary Outcome
Title Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab
Hide Description Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are type and number of dose limited toxicities observed.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from Cohort 3b who received at least one dose of study medication.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 0 0 0 14 0 0 0 0 0 0 0
Measure Type: Number
Unit of Measure: dose-limiting toxicities
Grade 3 amylase increased 1
Grade 4 lipase increased 1
11.Secondary Outcome
Title Safety: Percentage of Participants With Adverse Event
Hide Description An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame Up to approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of study medication.
Arm/Group Title Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib Cohort 2: Ovarian Cancer - Vemurafenib Cohort 3a: Colorectal Cancer - Vemurafenib Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Cohort 4: Cholangiocarcinoma - Vemurafenib Cohort 6: Multiple Myeloma - Vemurafenib Cohort 7a: ECD/LCH - Vemurafenib Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib Cohort 7d: Early Stage Astrocytoma - Vemurafenib Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
Hide Arm/Group Description:
Participants with NSCLC were treated with vemurafenib monotherapy.
Participants with ovarian cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib monotherapy.
Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
Participants with multiple myeloma were treated with vemurafenib monotherapy.
Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
Overall Number of Participants Analyzed 62 4 10 27 9 9 26 12 12 9 28
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100 100 100 100 91.7 100 100 100
Time Frame From baseline up to approximately 3 years
Adverse Event Reporting Description The safety population included all participants who received at least one dose of study medication.
 
Arm/Group Title Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Pooled Arm - Vemurafenib
Hide Arm/Group Description Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy. Participants with a variety of cancer types, who were treated with vemurafenib monotherapy, were combined into this arm.
All-Cause Mortality
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Pooled Arm - Vemurafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Pooled Arm - Vemurafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   11/27 (40.74%)   91/181 (50.28%) 
Blood and lymphatic system disorders     
Pseudolymphoma † 1  0/27 (0.00%)  1/181 (0.55%) 
Splenic infarction † 1  0/27 (0.00%)  1/181 (0.55%) 
Cardiac disorders     
Acute coronary syndrome † 1  0/27 (0.00%)  2/181 (1.10%) 
Pericarditis † 1  0/27 (0.00%)  2/181 (1.10%) 
Dressler's syndrome † 1  0/27 (0.00%)  1/181 (0.55%) 
Myocardial infarction † 1  0/27 (0.00%)  1/181 (0.55%) 
Pericardial effusion † 1  0/27 (0.00%)  1/181 (0.55%) 
Eye disorders     
Iridocyclitis † 1  0/27 (0.00%)  1/181 (0.55%) 
Gastrointestinal disorders     
Upper gastrointestinal haemorrhage † 1  1/27 (3.70%)  1/181 (0.55%) 
Subileus † 1  1/27 (3.70%)  0/181 (0.00%) 
Duodenal perforation † 1  0/27 (0.00%)  1/181 (0.55%) 
Dysphagia † 1  0/27 (0.00%)  1/181 (0.55%) 
Gastric ulcer † 1  0/27 (0.00%)  1/181 (0.55%) 
Stomatitis † 1  0/27 (0.00%)  1/181 (0.55%) 
General disorders     
Non-cardiac chest pain † 1  1/27 (3.70%)  0/181 (0.00%) 
Pyrexia † 1  1/27 (3.70%)  2/181 (1.10%) 
Fatigue † 1  0/27 (0.00%)  2/181 (1.10%) 
Chest pain † 1  0/27 (0.00%)  1/181 (0.55%) 
Hyperthermia † 1  0/27 (0.00%)  1/181 (0.55%) 
Hepatobiliary disorders     
Cholestasis † 1  1/27 (3.70%)  0/181 (0.00%) 
Bile duct obstruction † 1  0/27 (0.00%)  1/181 (0.55%) 
Drug-induced liver injury † 1  0/27 (0.00%)  1/181 (0.55%) 
Immune system disorders     
Hypersensitivity † 1  0/27 (0.00%)  1/181 (0.55%) 
Infections and infestations     
Sepsis † 1  0/27 (0.00%)  6/181 (3.31%) 
Pneumonia † 1  0/27 (0.00%)  5/181 (2.76%) 
Lung infection † 1  0/27 (0.00%)  4/181 (2.21%) 
Bronchitis † 1  0/27 (0.00%)  3/181 (1.66%) 
Lower respiratory tract infection † 1  0/27 (0.00%)  2/181 (1.10%) 
Abdominal abscess † 1  0/27 (0.00%)  1/181 (0.55%) 
Bacteraemia † 1  0/27 (0.00%)  1/181 (0.55%) 
Cellulitis † 1  0/27 (0.00%)  1/181 (0.55%) 
Diverticulitis † 1  0/27 (0.00%)  1/181 (0.55%) 
Furuncle † 1  0/27 (0.00%)  1/181 (0.55%) 
Septic shock † 1  0/27 (0.00%)  1/181 (0.55%) 
Soft tissue infection † 1  0/27 (0.00%)  1/181 (0.55%) 
Staphylococcal sepsis † 1  0/27 (0.00%)  1/181 (0.55%) 
Urinary tract infection † 1  0/27 (0.00%)  1/181 (0.55%) 
Injury, poisoning and procedural complications     
Femoral neck fracture † 1  1/27 (3.70%)  0/181 (0.00%) 
Fracture † 1  0/27 (0.00%)  1/181 (0.55%) 
Limb injury † 1  0/27 (0.00%)  1/181 (0.55%) 
Subdural haematoma † 1  0/27 (0.00%)  1/181 (0.55%) 
Investigations     
Gamma-glutamyltransferase increased † 1  1/27 (3.70%)  0/181 (0.00%) 
Body temperature increased † 1  0/27 (0.00%)  1/181 (0.55%) 
Metabolism and nutrition disorders     
Diabetes mellitus † 1  0/27 (0.00%)  1/181 (0.55%) 
Glucose tolerance impaired † 1  0/27 (0.00%)  1/181 (0.55%) 
Hypercalcaemia † 1  0/27 (0.00%)  1/181 (0.55%) 
Dehydration † 1  0/27 (0.00%)  3/181 (1.66%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  0/27 (0.00%)  1/181 (0.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma of skin † 1  3/27 (11.11%)  25/181 (13.81%) 
Keratoacanthoma † 1  2/27 (7.41%)  18/181 (9.94%) 
Basal cell carcinoma † 1  1/27 (3.70%)  7/181 (3.87%) 
Squamous cell carcinoma † 1  1/27 (3.70%)  1/181 (0.55%) 
Bowen's disease † 1  0/27 (0.00%)  4/181 (2.21%) 
Chronic myelomonocytic leukaemia † 1  0/27 (0.00%)  1/181 (0.55%) 
Papillary thyroid cancer † 1  0/27 (0.00%)  1/181 (0.55%) 
Paraganglion neoplasm † 1  0/27 (0.00%)  1/181 (0.55%) 
Skin cancer † 1  0/27 (0.00%)  1/181 (0.55%) 
Squamous cell carcinoma of lung † 1  0/27 (0.00%)  1/181 (0.55%) 
Nervous system disorders     
Aphasia † 1  0/27 (0.00%)  1/181 (0.55%) 
Brain oedema † 1  0/27 (0.00%)  1/181 (0.55%) 
Haemorrhagic stroke † 1  0/27 (0.00%)  1/181 (0.55%) 
Partial seizures † 1  0/27 (0.00%)  1/181 (0.55%) 
Peripheral motor neuropathy † 1  0/27 (0.00%)  1/181 (0.55%) 
Posterior reversible encephalopathy syndrome † 1  0/27 (0.00%)  1/181 (0.55%) 
Seizure † 1  0/27 (0.00%)  1/181 (0.55%) 
Transient ischaemic attack † 1  0/27 (0.00%)  1/181 (0.55%) 
Psychiatric disorders     
Delirium † 1  0/27 (0.00%)  1/181 (0.55%) 
Depression † 1  0/27 (0.00%)  1/181 (0.55%) 
Renal and urinary disorders     
Acute kidney injury † 1  1/27 (3.70%)  4/181 (2.21%) 
Bladder dilatation † 1  1/27 (3.70%)  0/181 (0.00%) 
Obstructive uropathy † 1  1/27 (3.70%)  0/181 (0.00%) 
Renal failure † 1  0/27 (0.00%)  1/181 (0.55%) 
Reproductive system and breast disorders     
Prostatitis † 1  0/27 (0.00%)  2/181 (1.10%) 
Benign prostatic hyperplasia † 1  0/27 (0.00%)  1/181 (0.55%) 
Uterine haemorrhage † 1  0/27 (0.00%)  1/181 (0.55%) 
Vaginal haemorrhage † 1  0/27 (0.00%)  1/181 (0.55%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary thrombosis † 1  1/27 (3.70%)  0/181 (0.00%) 
Dyspnoea † 1  0/27 (0.00%)  3/181 (1.66%) 
Pulmonary embolism † 1  0/27 (0.00%)  3/181 (1.66%) 
Respiratory failure † 1  0/27 (0.00%)  2/181 (1.10%) 
Laryngeal dyspnoea † 1  0/27 (0.00%)  1/181 (0.55%) 
Pleural effusion † 1  0/27 (0.00%)  1/181 (0.55%) 
Pneumothorax † 1  0/27 (0.00%)  1/181 (0.55%) 
Skin and subcutaneous tissue disorders     
Acute febrile neutrophilic dermatosis † 1  0/27 (0.00%)  1/181 (0.55%) 
Rash † 1  0/27 (0.00%)  1/181 (0.55%) 
Skin lesion † 1  0/27 (0.00%)  1/181 (0.55%) 
Vascular disorders     
Jugular vein thrombosis † 1  0/27 (0.00%)  1/181 (0.55%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab Pooled Arm - Vemurafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   26/27 (96.30%)   177/181 (97.79%) 
Blood and lymphatic system disorders     
Anaemia † 1  3/27 (11.11%)  30/181 (16.57%) 
Eye disorders     
Dry eye † 1  0/27 (0.00%)  11/181 (6.08%) 
Gastrointestinal disorders     
Abdominal pain † 1  12/27 (44.44%)  12/181 (6.63%) 
Abdominal pain upper † 1  4/27 (14.81%)  0/181 (0.00%) 
Constipation † 1  5/27 (18.52%)  26/181 (14.36%) 
Diarrhoea † 1  13/27 (48.15%)  49/181 (27.07%) 
Dyspepsia † 1  2/27 (7.41%)  0/181 (0.00%) 
Flatulence † 1  2/27 (7.41%)  0/181 (0.00%) 
Nausea † 1  9/27 (33.33%)  54/181 (29.83%) 
Rectal haemorrhage † 1  2/27 (7.41%)  0/181 (0.00%) 
Stomatitis † 1  4/27 (14.81%)  19/181 (10.50%) 
Vomiting † 1  8/27 (29.63%)  41/181 (22.65%) 
Dry mouth † 1  0/27 (0.00%)  12/181 (6.63%) 
Dysphagia † 1  0/27 (0.00%)  14/181 (7.73%) 
General disorders     
Asthenia † 1  10/27 (37.04%)  39/181 (21.55%) 
Chest pain † 1  2/27 (7.41%)  0/181 (0.00%) 
Chills † 1  2/27 (7.41%)  10/181 (5.52%) 
Fatigue † 1  6/27 (22.22%)  60/181 (33.15%) 
Oedema peripheral † 1  4/27 (14.81%)  21/181 (11.60%) 
Pyrexia † 1  5/27 (18.52%)  26/181 (14.36%) 
Cyst † 1  0/27 (0.00%)  21/181 (11.60%) 
Xerosis † 1  0/27 (0.00%)  16/181 (8.84%) 
Hepatobiliary disorders     
Hyperbilirubinaemia † 1  0/27 (0.00%)  11/181 (6.08%) 
Infections and infestations     
Conjunctivitis † 1  3/27 (11.11%)  0/181 (0.00%) 
Folliculitis † 1  3/27 (11.11%)  18/181 (9.94%) 
Oral candidiasis † 1  2/27 (7.41%)  0/181 (0.00%) 
Rash pustular † 1  3/27 (11.11%)  0/181 (0.00%) 
Skin infection † 1  2/27 (7.41%)  0/181 (0.00%) 
Urinary tract infection † 1  3/27 (11.11%)  0/181 (0.00%) 
Injury, poisoning and procedural complications     
Fall † 1  2/27 (7.41%)  0/181 (0.00%) 
Sunburn † 1  4/27 (14.81%)  22/181 (12.15%) 
Investigations     
Amylase increased † 1  6/27 (22.22%)  0/181 (0.00%) 
Aspartate aminotransferase increased † 1  2/27 (7.41%)  15/181 (8.29%) 
Blood bilirubin increased † 1  3/27 (11.11%)  10/181 (5.52%) 
Electrocardiogram QT prolonged † 1  4/27 (14.81%)  37/181 (20.44%) 
Lipase increased † 1  9/27 (33.33%)  10/181 (5.52%) 
Lymphocyte count decreased † 1  3/27 (11.11%)  0/181 (0.00%) 
Weight decreased † 1  6/27 (22.22%)  20/181 (11.05%) 
Alanine aminotransferase increased † 1  0/27 (0.00%)  15/181 (8.29%) 
Blood alkaline phosphatase increased † 1  0/27 (0.00%)  11/181 (6.08%) 
Blood creatinine increased † 1  0/27 (0.00%)  19/181 (10.50%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  10/27 (37.04%)  50/181 (27.62%) 
Dehydration † 1  2/27 (7.41%)  0/181 (0.00%) 
Hyperglycaemia † 1  2/27 (7.41%)  0/181 (0.00%) 
Hypoalbuminaemia † 1  2/27 (7.41%)  0/181 (0.00%) 
Hypokalaemia † 1  5/27 (18.52%)  18/181 (9.94%) 
Hyponatraemia † 1  2/27 (7.41%)  0/181 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  14/27 (51.85%)  79/181 (43.65%) 
Back pain † 1  4/27 (14.81%)  18/181 (9.94%) 
Muscle spasms † 1  2/27 (7.41%)  0/181 (0.00%) 
Myalgia † 1  3/27 (11.11%)  18/181 (9.94%) 
Pain in extremity † 1  2/27 (7.41%)  13/181 (7.18%) 
Musculoskeletal pain † 1  0/27 (0.00%)  14/181 (7.73%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acrochordon † 1  2/27 (7.41%)  0/181 (0.00%) 
Melanocytic naevus † 1  4/27 (14.81%)  41/181 (22.65%) 
Seborrhoeic keratosis † 1  3/27 (11.11%)  36/181 (19.89%) 
Skin papilloma † 1  7/27 (25.93%)  50/181 (27.62%) 
Papilloma † 1  0/27 (0.00%)  17/181 (9.39%) 
Nervous system disorders     
Headache † 1  4/27 (14.81%)  26/181 (14.36%) 
Dysgeusia † 1  0/27 (0.00%)  24/181 (13.26%) 
Peripheral sensory neuropathy † 1  0/27 (0.00%)  27/181 (14.92%) 
Psychiatric disorders     
Anxiety † 1  2/27 (7.41%)  14/181 (7.73%) 
Depression † 1  3/27 (11.11%)  10/181 (5.52%) 
Insomnia † 1  0/27 (0.00%)  18/181 (9.94%) 
Renal and urinary disorders     
Haematuria † 1  2/27 (7.41%)  0/181 (0.00%) 
Micturition urgency † 1  2/27 (7.41%)  0/181 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  2/27 (7.41%)  31/181 (17.13%) 
Dysphonia † 1  2/27 (7.41%)  0/181 (0.00%) 
Dyspnoea † 1  5/27 (18.52%)  22/181 (12.15%) 
Nasal congestion † 1  0/27 (0.00%)  10/181 (5.52%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis † 1  4/27 (14.81%)  28/181 (15.47%) 
Alopecia † 1  2/27 (7.41%)  57/181 (31.49%) 
Dermatitis acneiform † 1  2/27 (7.41%)  0/181 (0.00%) 
Dermatitis bullous † 1  2/27 (7.41%)  0/181 (0.00%) 
Dry skin † 1  2/27 (7.41%)  39/181 (21.55%) 
Erythema † 1  7/27 (25.93%)  24/181 (13.26%) 
Hyperkeratosis † 1  4/27 (14.81%)  58/181 (32.04%) 
Photosensitivity reaction † 1  5/27 (18.52%)  39/181 (21.55%) 
Pruritus † 1  5/27 (18.52%)  42/181 (23.20%) 
Rash † 1  10/27 (37.04%)  44/181 (24.31%) 
Rash generalised † 1  2/27 (7.41%)  0/181 (0.00%) 
Rash maculo-papular † 1  3/27 (11.11%)  42/181 (23.20%) 
Skin fissures † 1  2/27 (7.41%)  0/181 (0.00%) 
Toxic skin eruption † 1  2/27 (7.41%)  0/181 (0.00%) 
Dermal cyst † 1  0/27 (0.00%)  18/181 (9.94%) 
Dermatitis † 1  0/27 (0.00%)  10/181 (5.52%) 
Keratosis pilaris † 1  0/27 (0.00%)  33/181 (18.23%) 
Milia † 1  0/27 (0.00%)  16/181 (8.84%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  0/27 (0.00%)  48/181 (26.52%) 
Papule † 1  0/27 (0.00%)  13/181 (7.18%) 
Rash papular † 1  0/27 (0.00%)  21/181 (11.60%) 
Skin lesion † 1  0/27 (0.00%)  11/181 (6.08%) 
Vascular disorders     
Hypertension † 1  3/27 (11.11%)  28/181 (15.47%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01524978    
Other Study ID Numbers: MO28072
2011-004426-10 ( EudraCT Number )
First Submitted: January 27, 2012
First Posted: February 2, 2012
Results First Submitted: August 22, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017