Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01378975
First received: June 21, 2011
Last updated: June 20, 2016
Last verified: April 2016
Results First Received: June 20, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Drug: Vemurafenib

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Cohort 1: Previously Untreated Participants Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
Cohort 2: Previously Treated Participants Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.

Participant Flow:   Overall Study
    Cohort 1: Previously Untreated Participants     Cohort 2: Previously Treated Participants  
STARTED     90     56  
COMPLETED     4     6  
NOT COMPLETED     86     50  
Death                 77                 46  
Investigator Request                 1                 0  
Lost to Follow-up                 4                 1  
Withdrew Consent                 4                 3  



  Baseline Characteristics
  Hide 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.
The intent-to-treat (ITT) population included all participants who were enrolled in the study.

Reporting Groups
  Description
Cohort 1: Previously Untreated Participants Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
Cohort 2: Previously Treated Participants Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
Total Total of all reporting groups

Baseline Measures
    Cohort 1: Previously Untreated Participants     Cohort 2: Previously Treated Participants     Total  
Number of Participants  
[units: participants]
  90     56     146  
Age  
[units: years]
Mean (Standard Deviation)
  55.7  (12.73)     52.7  (13.85)     54.5  (13.20)  
Gender  
[units: participants]
     
Female     34     22     56  
Male     56     34     90  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST])   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

2.  Secondary:   Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

3.  Secondary:   Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated Brain Metastases as Assessed by the IRC Using RECIST v1.1   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

4.  Secondary:   Best Overall Response Rate Outside the Brain (Assessed by IRC)   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

5.  Secondary:   Duration of Response (DOR) (Assessed by Investigator and IRC)   [ Time Frame: Date of the earliest qualifying response until the earliest date of PD or death from any cause (approximately up to 4 years) ]

6.  Secondary:   Progression-Free Survival (PFS) Based on Overall Tumor Response (Assessed by Investigator)   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

7.  Secondary:   Progression-Free Survival (PFS) Based on Tumor Assessment Within Brain Only (Assessed by Investigator )   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

8.  Secondary:   Time to Development of New Brain Metastases in Responders   [ Time Frame: Date of first treatment and the earliest date of documentation of new brain lesions (approximately up to 4 years) ]

9.  Secondary:   Overall Survival   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

10.  Secondary:   Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Assessed by Investigator)   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

11.  Secondary:   Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Not Necessarily Follows the RECIST Criteria - as Assessed by Investigator)   [ Time Frame: Baseline up to the disease progression or death from any cause (approximately 4 years) ]

12.  Secondary:   Percentage of Participants With Adverse Events (AE)   [ Time Frame: From signing of informed consent form up to 28 days after the last dose of study drug (approximately up to 4 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01378975     History of Changes
Other Study ID Numbers: MO25743
Study First Received: June 21, 2011
Results First Received: June 20, 2016
Last Updated: June 20, 2016
Health Authority: United States: Food and Drug Administration