BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

This study has been terminated.
(Study was terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01519323
First received: January 16, 2012
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: June 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Drug: vemurafenib

  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
First investigational site was activated on 22 December 2011.

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
Vemurafenib Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.

Participant Flow:   Overall Study
    Vemurafenib  
STARTED     6  
COMPLETED     0  
NOT COMPLETED     6  
Death                 5  
Study terminated by sponsor                 1  



  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 vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.

Baseline Measures
    Vemurafenib  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Mean (Standard Deviation)
  15.8  (0.8)  
Gender  
[units: participants]
 
Female     2  
Male     4  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD)/Recommended Dose   [ Time Frame: Up to 28 days of treatment ]

2.  Secondary:   Area Under the Concentration-Time Curve for Vemurafenib   [ Time Frame: Cycle 1 Day 1 and Cycle 1 Day 22 (each cycle is of 28 days) ]

3.  Secondary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to approximately 2 years 11 months ]

4.  Secondary:   Best Overall Response Rate (BORR)   [ Time Frame: Up to 2 years ]

5.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Up to 2 years ]

6.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Randomization date of first subject until disease progression or death or which ever occur first (2 years) ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: Randomization date of first subject until death (2 years) ]


  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
The study was prematurely terminated on 18 December 2015 by the Sponsor due to recruitment challenges and therefore low enrollment.


  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: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01519323     History of Changes
Other Study ID Numbers: NO25390
2011-000874-67 ( EudraCT Number )
Study First Received: January 16, 2012
Results First Received: June 17, 2016
Last Updated: June 17, 2016
Health Authority: United States: Food and Drug Administration