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A Study of Vemurafenib in Participants With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01307397
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Malignant Melanoma
Intervention: Drug: Vemurafenib

  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
Vemurafenib Participants received continuous oral doses of vemurafenib 960 milligrams (mg) (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.

Participant Flow:   Overall Study
    Vemurafenib
STARTED   3219 
COMPLETED   3219 [1] 
NOT COMPLETED   0 
[1] A participant completed study in case of progressive disease, adverse events or consent withdrawn



  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 safety population included all participants who received at least one dose of study medication.

Reporting Groups
  Description
Vemurafenib Participants received continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant’s safety, death or study termination by the Sponsor.

Baseline Measures
   Vemurafenib 
Overall Participants Analyzed 
[Units: Participants]
 3219 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (14.06) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1397  43.4% 
Male      1822  56.6% 


  Outcome Measures

1.  Primary:   Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0   [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]

2.  Primary:   Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation   [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]

3.  Primary:   Percentage of Participants With AEs of Special Interest   [ Time Frame: Baseline up to 28 days post end of treatment (maximum up to 46 months) ]

4.  Primary:   Mean Cumulative Dose of Vemurafenib   [ Time Frame: Baseline up to end of treatment or death (maximum up to 46 months) ]

5.  Primary:   Duration of Vemurafenib Treatment   [ Time Frame: Baseline up to end of treatment or death (maximum upto 46 months) ]

6.  Primary:   Mean Total Vemurafenib Dose Per Day   [ Time Frame: Baseline up to end of treatment or death (maximum up to 46 months) ]

7.  Primary:   Dose Intensity of Vemurafenib   [ Time Frame: Baseline up to end of treatment or death (maximum upto 46 months) ]

8.  Secondary:   Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status   [ Time Frame: Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months) ]

9.  Secondary:   Percentage of Participants Who Received Any Concomitant Medications   [ Time Frame: Baseline up to 46 months ]

10.  Secondary:   Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)   [ Time Frame: Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]

11.  Secondary:   Duration of Response   [ Time Frame: From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months]) ]

12.  Secondary:   Time to Response   [ Time Frame: Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]

13.  Secondary:   Percentage of Participants With PD Assessed According to RECIST v1.1 or Death   [ Time Frame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]

14.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months]) ]

15.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline until death (maximum up to 46 months) ]

16.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death (maximum up to 46 months) ]


  Serious Adverse Events


  Other Adverse Events


  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

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


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01307397     History of Changes
Other Study ID Numbers: MO25515
2010-023526-21 ( EudraCT Number )
First Submitted: February 17, 2011
First Posted: March 2, 2011
Results First Submitted: July 21, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017