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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 ]

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 ]

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


  Serious Adverse Events
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Time Frame Screening through 6 months after the last patient enrolled
Additional Description 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.

Serious Adverse Events
    Vemurafenib 960 mg  
Total, serious adverse events    
# participants affected / at risk     67/132 (50.76%)  
Blood and lymphatic system disorders    
ANAEMIA † 1  
# participants affected / at risk     1/132 (0.76%)  
Cardiac disorders    
PERICARDIAL EFFUSION † 1  
# participants affected / at risk     2/132 (1.52%)  
ANGINA PECTORIS † 1  
# participants affected / at risk     1/132 (0.76%)  
PERICARDITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
ATRIAL FLUTTER † 1  
# participants affected / at risk     1/132 (0.76%)  
Eye disorders    
RETINAL VEIN OCCLUSION † 1  
# participants affected / at risk     1/132 (0.76%)  
Gastrointestinal disorders    
DYSPHAGIA † 1  
# participants affected / at risk     3/132 (2.27%)  
ABDOMINAL PAIN UPPER † 1  
# participants affected / at risk     2/132 (1.52%)  
NAUSEA † 1  
# participants affected / at risk     2/132 (1.52%)  
ABDOMINAL PAIN † 1  
# participants affected / at risk     1/132 (0.76%)  
DIARRHOEA † 1  
# participants affected / at risk     1/132 (0.76%)  
GASTROINTESTINAL HAEMORRHAGE † 1  
# participants affected / at risk     1/132 (0.76%)  
OESOPHAGITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
PANCREATITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
VOMITING † 1  
# participants affected / at risk     1/132 (0.76%)  
General disorders    
PYREXIA † 1  
# participants affected / at risk     3/132 (2.27%)  
MULTI-ORGAN FAILURE † 1  
# participants affected / at risk     1/132 (0.76%)  
PAIN † 1  
# participants affected / at risk     1/132 (0.76%)  
Hepatobiliary disorders    
CHOLECYSTITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
HEPATIC CYST † 1  
# participants affected / at risk     1/132 (0.76%)  
JAUNDICE † 1  
# participants affected / at risk     1/132 (0.76%)  
Infections and infestations    
PNEUMONIA † 1  
# participants affected / at risk     3/132 (2.27%)  
CELLULITIS † 1  
# participants affected / at risk     2/132 (1.52%)  
BREAST CELLULITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
PSEUDOMONAS INFECTION † 1  
# participants affected / at risk     1/132 (0.76%)  
SALMONELLOSIS † 1  
# participants affected / at risk     1/132 (0.76%)  
SKIN INFECTION † 1  
# participants affected / at risk     1/132 (0.76%)  
STAPHYLOCOCCAL INFECTION † 1  
# participants affected / at risk     1/132 (0.76%)  
WOUND INFECTION † 1  
# participants affected / at risk     1/132 (0.76%)  
Injury, poisoning and procedural complications    
FEMUR FRACTURE † 1  
# participants affected / at risk     1/132 (0.76%)  
Investigations    
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1  
# participants affected / at risk     3/132 (2.27%)  
BLOOD ALKALINE PHOSPHATASE INCREASED † 1  
# participants affected / at risk     2/132 (1.52%)  
BLOOD BILIRUBIN INCREASED † 1  
# participants affected / at risk     2/132 (1.52%)  
ALANINE AMINOTRANSFERASE INCREASED † 1  
# participants affected / at risk     1/132 (0.76%)  
BILIRUBIN CONJUGATED INCREASED † 1  
# participants affected / at risk     1/132 (0.76%)  
Metabolism and nutrition disorders    
DEHYDRATION † 1  
# participants affected / at risk     2/132 (1.52%)  
TUMOUR LYSIS SYNDROME † 1  
# participants affected / at risk     1/132 (0.76%)  
Musculoskeletal and connective tissue disorders    
ARTHRALGIA † 1  
# participants affected / at risk     2/132 (1.52%)  
ARTHRITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
MUSCULAR WEAKNESS † 1  
# participants affected / at risk     1/132 (0.76%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
SQUAMOUS CELL CARCINOMA OF SKIN † 1  
# participants affected / at risk     28/132 (21.21%)  
BASAL CELL CARCINOMA † 1  
# participants affected / at risk     8/132 (6.06%)  
KERATOACANTHOMA † 1  
# participants affected / at risk     6/132 (4.55%)  
MALIGNANT MELANOMA † 1  
# participants affected / at risk     2/132 (1.52%)  
Nervous system disorders    
CONVULSION † 1  
# participants affected / at risk     3/132 (2.27%)  
FACIAL PALSY † 1  
# participants affected / at risk     3/132 (2.27%)  
Psychiatric disorders    
DELIRIUM † 1  
# participants affected / at risk     1/132 (0.76%)  
PSYCHOTIC DISORDER † 1  
# participants affected / at risk     1/132 (0.76%)  
Renal and urinary disorders    
RENAL FAILURE † 1  
# participants affected / at risk     1/132 (0.76%)  
RENAL FAILURE ACUTE † 1  
# participants affected / at risk     1/132 (0.76%)  
Respiratory, thoracic and mediastinal disorders    
PULMONARY EMBOLISM † 1  
# participants affected / at risk     3/132 (2.27%)  
DYSPNOEA † 1  
# participants affected / at risk     1/132 (0.76%)  
RESPIRATORY FAILURE † 1  
# participants affected / at risk     1/132 (0.76%)  
LEFT LUNG GROUND GLASS OPACITIES-PNEUMONITIS † 1  
# participants affected / at risk     1/132 (0.76%)  
Skin and subcutaneous tissue disorders    
EXFOLIATIVE RASH † 1  
# participants affected / at risk     1/132 (0.76%)  
RASH † 1  
# participants affected / at risk     1/132 (0.76%)  
RASH VESICULAR † 1  
# participants affected / at risk     1/132 (0.76%)  
Vascular disorders    
DEEP VEIN THROMBOSIS † 1  
# participants affected / at risk     1/132 (0.76%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0




  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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