A Study of RO5185426 in Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01248936
First received: November 24, 2010
Last updated: January 13, 2016
Last verified: January 2016
Results First Received: January 13, 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: RO5185426

  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
The study was conducted in 29 study sites in the United States (US). The study period was from 10 December 2010 to 24 October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 745 participants were screened during the study, of which 374 were randomized to receive study treatment; the main reason for screen failure was negative cobas test, consent withdrawal, BRAF test not performed, patient died or progressed, and other unspecified reasons. Of 374 participants, 3 did not receive treatment after enrollment.

Reporting Groups
  Description
Overall Trial Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.

Participant Flow:   Overall Study
    Overall Trial  
STARTED     374  
COMPLETED     0  
NOT COMPLETED     374  
Sponsor Decision                 259  
Progression of Disease                 50  
Death                 26  
Withdrawal of Consent                 20  
Adverse Event                 8  
Lost to Follow-up                 7  
Refused Treatment                 1  
Other reason                 3  



  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
Overall Trial Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.

Baseline Measures
    Overall Trial  
Number of Participants  
[units: participants]
  371  
Age  
[units: years]
Mean (Standard Deviation)
  53.5  (13.8)  
Age, Customized  
[units: participants]
 
Adolescents (12-17 year)     1  
From 18 - 64 years     289  
From 65 – 84 years     79  
Over 85 years     2  
Gender  
[units: participants]
 
Female     142  
Male     229  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation   [ Time Frame: Up to 1 year ]

2.  Primary:   Number of Participants With Any Serious Adverse Event, Death and Cause of Death   [ Time Frame: Up to 1 year ]

3.  Secondary:   Number of Participants With Best Overall Response (Unconfirmed)   [ Time Frame: Up to 1 year ]

4.  Secondary:   Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance   [ Time Frame: Up to 1 year ]

5.  Secondary:   Number of Participants With Best Overall Response (Confirmed)   [ Time Frame: Up to 1 year ]

6.  Secondary:   Number of Participants With Best Overall Response (Confirmed) by ECOG Performance   [ Time Frame: Up to 1 year ]

7.  Secondary:   Mean Time to Complete Response/Partial Response   [ Time Frame: Up to 1 year ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01248936     History of Changes
Other Study ID Numbers: ML25597
Study First Received: November 24, 2010
Results First Received: January 13, 2016
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration