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
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 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.
No text entered.

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 ]

Measure Type Primary
Measure Title Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Measure Description BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  52.3  
  ( 43.4 to 61.0 )  

No statistical analysis provided for Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)



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 ]

Measure Type Secondary
Measure Title Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Measure Description BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  54.5  
  ( 45.7 to 63.2 )  

No statistical analysis provided for Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)



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 ]

Measure Type Secondary
Measure Title Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Measure Description Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  69  
Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)  
[units: Months]
Median ( 95% Confidence Interval )
  6.5  
  ( 5.6 to NA ) [1]
[1] The upper limit of the confidence interval was not estimable because a large percentage of patients (57%) were progression-free at the data cutoff date and had censored data.

No statistical analysis provided for Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)



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 ]

Measure Type Secondary
Measure Title Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Measure Description Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  69  
Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)  
[units: Months]
Median ( Inter-Quartile Range )
  1.38  
  ( 1.3 to 1.6 )  

No statistical analysis provided for Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)



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 ]

Measure Type Secondary
Measure Title Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)
Measure Description PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)  
[units: Months]
Median ( 95% Confidence Interval )
  6.1  
  ( 5.5 to 6.9 )  

No statistical analysis provided for Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)



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

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
Overall Survival  
[units: Months]
Median ( 95% Confidence Interval )
  NA  
  ( 9.5 to NA ) [1]
[1] The median and the upper limit of the confidence interval were not estimable because a large percentage of patients (69%) were alive at the data cutoff date.

No statistical analysis provided for Overall Survival



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 ]

Measure Type Secondary
Measure Title 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
Measure Description Three parameters were measured. (1) Improvement in the Physician’s Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.
Time Frame From first treatment through September 27, 2010  
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.
Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
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  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
 
Improvement in performance status     83.3  
  ( 80.0 to 90.0 )  
Improvement in oxygen saturation requirement     4.5  
  ( 0.0 to 10.0 )  
Decrease in use of narcotic pain analgesics     3.0  
  ( 0.0 to 10.0 )  

No statistical analysis provided for 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



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 ]

Measure Type Secondary
Measure Title Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1
Measure Description Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).
Time Frame Pre-dose to 8 hours post-dose on Day 15 of Cycle 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]
  87  
Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1  
[units: μg/mL]
Mean ± Standard Deviation
  56.73  ± 21.76  

No statistical analysis provided for Maximum Plasma Concentration (Cmax) of Vemurafenib 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 ]

Measure Type Secondary
Measure Title Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1
Measure Description Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.
Time Frame Pre-dose to 8 hours post-dose on Day 15 of Cycle 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]
  87  
Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1  
[units: μg⋅h/mL]
Mean ± Standard Deviation
  380.16  ± 143.56  

No statistical analysis provided for Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) 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 ]

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 ]

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  
Safety Issue Yes  

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  
Number of 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  
  ( NA to 14.9 ) [1]
Cycle 6 Day 1 at pre-dose, n=85     15.1  
  ( NA to 17.7 ) [1]
[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 ]

Measure Type Secondary
Measure Title Percentage of Patients With Adverse Event
Measure Description The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).
Time Frame From first treatment through September 27, 2010  
Safety Issue Yes  

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 population: All enrolled patients who received at least one, or a partial dose of vemurafenib.

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]
  132  
Percentage of Patients With Adverse Event  
[units: Percentage of participants]
  100.0  

No statistical analysis provided for Percentage of Patients With Adverse Event




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


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