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

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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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    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
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 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all participants enrolled in the study irrespective of whether they had received study medication or not.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 62   4   10   27   9   9   26   12   12   9   28   208 
Age 
[Units: Years]
Mean (Standard Deviation)
 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 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Confirmed Best Overall Response Rate (BORR)   [ Time Frame: Up to approximately 3 years ]

2.  Secondary:   Percentage of Participants With Confirmed Clinical Benefit   [ Time Frame: Up to approximately 3 years ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Up to approximately 3 years ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: Up to approximately 3 years ]

5.  Secondary:   Time to Response   [ Time Frame: Up to approximately 3 years ]

6.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Up to approximately 3 years ]

7.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to approximately 3 years ]

8.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to approximately 3 years ]

9.  Secondary:   Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab   [ Time Frame: Up to approximately 3 years ]

10.  Secondary:   Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab   [ Time Frame: Up to 28 days ]

11.  Secondary:   Safety: Percentage of Participants With Adverse Event   [ Time Frame: Up to approximately 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01524978     History of Changes
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