A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00949702
First received: July 28, 2009
Last updated: December 19, 2012
Last verified: December 2012
Results First Received: July 29, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vemurafenib 960 mg Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.

Participant Flow:   Overall Study
    Vemurafenib 960 mg  
STARTED     132  
COMPLETED     84  
NOT COMPLETED     48  
Death                 40  
Disease progression                 7  
Withdrawal of consent                 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.
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Reporting Groups
  Description
Vemurafenib 960 mg Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.

Baseline Measures
    Vemurafenib 960 mg  
Number of Participants  
[units: participants]
  132  
Age  
[units: years]
Mean ± Standard Deviation
  50.3  ± 14.70  
Gender  
[units: participants]
 
Female     51  
Male     81  



  Outcome Measures
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1.  Primary:   Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)   [ Time Frame: From first treatment through September 27, 2010 ]

2.  Secondary:   Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)   [ Time Frame: From first treatment through September 27, 2010 ]

3.  Secondary:   Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)   [ Time Frame: From first treatment through September 27, 2010 ]

4.  Secondary:   Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)   [ Time Frame: From first treatment through September 27, 2010 ]

5.  Secondary:   Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)   [ Time Frame: From first treatment through September 27, 2010 ]

6.  Secondary:   Overall Survival   [ Time Frame: From first treatment through September 27, 2010 ]

7.  Secondary:   Improvement in Physical Symptoms (Improvement in Physician’s Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline   [ Time Frame: From first treatment through September 27, 2010 ]

8.  Secondary:   Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1   [ Time Frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 ]

9.  Secondary:   Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1   [ Time Frame: Pre-dose to 8 hours post-dose on Day 15 of Cycle 1 ]

10.  Secondary:   Vemurafenib Plasma Levels at Various Treatment Cycles   [ Time Frame: Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1 ]
  Hide Outcome Measure 10

Measure Type Secondary
Measure Title Vemurafenib Plasma Levels at Various Treatment Cycles
Measure Description Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.
Time Frame Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1  
Safety Issue No  

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.
Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.

Reporting Groups
  Description
Vemurafenib 960 mg Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.

Measured Values
    Vemurafenib 960 mg  
Number of Participants Analyzed  
[units: participants]
  122  
Vemurafenib Plasma Levels at Various Treatment Cycles  
[units: μg/mL]
Mean ± Standard Deviation
 
Pre-dose Cycle 1 Day 15, n=108     47.55  ± 23.14  
Pre-dose Cycle 2 Day 1, n=122     41.12  ± 23.39  
Pre-dose Cycle 3 Day 1, n=109     45.20  ± 21.33  
Pre-dose Cycle 4 Day 1, n=109     50.31  ± 19.52  
Pre-dose Cycle 6 Day 1, n=96     50.38  ± 19.54  
Pre-dose Cycle 8 Day 1, n=71     50.42  ± 22.06  
Pre-dose Cycle 10 Day 1, n=50     50.78  ± 20.19  
4 hours post-dose Cycle 2 Day 22, n=93     48.38  ± 20.00  
4 hours post-dose Cycle 3 Day 43, n=78     50.79  ± 19.20  
4 hours post-dose Cycle 4 Day 1, n=75     55.76  ± 20.57  
4 hours post-dose Cycle 6 Day 1, n=58     58.92  ± 20.12  
4 hours post-dose Cycle 8 Day 1, n=43     58.95  ± 20.98  
4 hours post-dose Cycle 10 Day 1, n=27     63.27  ± 21.52  

No statistical analysis provided for Vemurafenib Plasma Levels at Various Treatment Cycles



11.  Secondary:   Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)   [ Time Frame: Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1 ]

12.  Secondary:   Percentage of Patients With Adverse Event   [ Time Frame: From first treatment through September 27, 2010 ]


  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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