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A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01006980
First received: October 30, 2009
Last updated: August 19, 2016
Last verified: December 2015
Results First Received: July 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Interventions: Drug: Vemurafenib
Drug: Dacarbazine

  Participant Flow
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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
675 participants were randomized, 337 to vemurafenib and 338 to dacarbazine. One participant randomized to dacarbazine was treated in error with vemurafenib throughout the study and is included in the Vemurafenib arm in the table below and for exposure and safety analyses and is included in the dacarbazine arm for efficacy analyses.

Reporting Groups
  Description
Vemurafenib Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
Dacarbazine Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).

Participant Flow for 2 periods

Period 1:   Vemurafenib and Dacarbazine
    Vemurafenib   Dacarbazine
STARTED   337   338 
Treated   336   293 
COMPLETED   0   0 
NOT COMPLETED   337   338 
Randomized but Not Treated                1                45 
Adverse Event                25                5 
Death                13                12 
Progression                257                218 
Withdrawal of Consent                4                6 
Refuse Treatment                9                6 
Protocol Violation                2                3 
Reason Not Specified                26                43 

Period 2:   Crossover: Dacarbazine to Vemurafenib
    Vemurafenib   Dacarbazine
STARTED   0   84 [1] 
COMPLETED   0   0 
NOT COMPLETED   0   84 
Adverse Event                0                4 
Death                0                4 
Progression                0                65 
Withdrawal of Consent                0                1 
Reason Not Specified                0                10 
[1] Participants who crossed over from dacarbazine to vemurafenib treatment.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Vemurafenib Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
Dacarbazine Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
Total Total of all reporting groups

Baseline Measures
   Vemurafenib   Dacarbazine   Total 
Overall Participants Analyzed 
[Units: Participants]
 337   338   675 
Age, Customized 
[Units: Participants]
     
< 65 years   244   270   514 
>=65 years   93   68   161 
Gender 
[Units: Participants]
     
Female   137   157   294 
Male   200   181   381 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3). ]

2.  Primary:   Progression-free Survival   [ Time Frame: From randomization (initiated January 2010) to December 30 2010. ]

3.  Secondary:   Participants With a Best Overall Response (BOR) of Complete Response or Partial Response   [ Time Frame: From randomization (initiated January 2010) until December 30, 2010 ]

4.  Secondary:   Duration of Response   [ Time Frame: From randomization (initiated in January 2010) until December 30, 2010. ]

5.  Secondary:   Time to Confirmed Response   [ Time Frame: From randomization (initiated January 2010) until December 30, 2010. ]

6.  Secondary:   Time to Treatment Failure   [ Time Frame: approximately 3 years ]

7.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From randomization (initiated January 2010) until December 30, 2010. ]

8.  Secondary:   Pre and Post-dose Plasma Vemurafenib Concentration by Study Day   [ Time Frame: Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Hoffman-LaRoche
phone: 800-821-8590


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


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01006980     History of Changes
Other Study ID Numbers: NO25026
2009-012293-12
Study First Received: October 30, 2009
Results First Received: July 29, 2011
Last Updated: August 19, 2016