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Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

This study has been terminated.
(Recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01586195
First received: April 24, 2012
Last updated: April 24, 2017
Last verified: April 2017
Results First Received: July 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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
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
Vemurafenib Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.

Participant Flow:   Overall Study
    Vemurafenib
STARTED   31 
COMPLETED   5 
NOT COMPLETED   26 
Death                11 
Withdrawal of Consent                5 
Started new anti-melanoma therapy                1 
Reason not specified                9 



  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.
Intent to treat (ITT) population defined as all enrolled participants who received any amount of study drug.

Reporting Groups
  Description
Vemurafenib Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.

Baseline Measures
   Vemurafenib 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.0  (11.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  12.9% 
Male      27  87.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Objective Response Rate (BORR)   [ Time Frame: Up to 42 months ]

2.  Secondary:   Time to BORR   [ Time Frame: From start of treatment up to first documentation of confirmed CR or PR (up to 42 months) ]

3.  Secondary:   Duration of Response   [ Time Frame: From date of earliest qualifying response up to date of disease progression or death (up to 42 months) ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From start of treatment up to first documentation of disease progression or death (up to 42 months) ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Date of first treatment to date of death due to any cause (up to 42 months) ]

6.  Secondary:   Percentage of Participants With 6-Month Survival   [ Time Frame: Baseline to Month 6 ]

7.  Secondary:   Percentage of Participants With 12-Month Survival   [ Time Frame: Baseline to Month 12 ]

8.  Secondary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to 42 months ]


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



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01586195     History of Changes
Other Study ID Numbers: ML27763
Study First Received: April 24, 2012
Results First Received: July 7, 2016
Last Updated: April 24, 2017