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A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Hoffmann-La Roche.
Recruitment status was:  Active, not recruiting
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;   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 
Overall Participants Analyzed 
[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 ]

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 ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)
Measure Description Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.
Time Frame Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1  

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.
Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.

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 
Participants Analyzed 
[Units: Participants]
 128 
Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP) 
[Units: Ms]
Mean (95% Confidence Interval)
 
Cycle 1 Day 15 at 2 hours post-dose, n=109   12.8 [1] 
 (N/A to 14.9) 
Cycle 6 Day 1 at pre-dose, n=85   15.1 [1] 
 (N/A to 17.7) 
[1] This is a one-sided confidence interval.

No statistical analysis provided for Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)



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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