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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;   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
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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 ]

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame Screening through 6 months after the last patient enrolled
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    Vemurafenib 960 mg
Total, other (not including serious) adverse events   
# participants affected / at risk   131/132 (99.24%) 
Blood and lymphatic system disorders   
ANAEMIA † 1   
# participants affected / at risk   11/132 (8.33%) 
Eye disorders   
VISION BLURRED † 1   
# participants affected / at risk   7/132 (5.30%) 
Gastrointestinal disorders   
NAUSEA † 1   
# participants affected / at risk   47/132 (35.61%) 
DIARRHOEA † 1   
# participants affected / at risk   37/132 (28.03%) 
VOMITING † 1   
# participants affected / at risk   33/132 (25.00%) 
CONSTIPATION † 1   
# participants affected / at risk   21/132 (15.91%) 
ABDOMINAL PAIN † 1   
# participants affected / at risk   12/132 (9.09%) 
DYSPEPSIA † 1   
# participants affected / at risk   11/132 (8.33%) 
General disorders   
FATIGUE † 1   
# participants affected / at risk   71/132 (53.79%) 
OEDEMA PERIPHERAL † 1   
# participants affected / at risk   30/132 (22.73%) 
PYREXIA † 1   
# participants affected / at risk   20/132 (15.15%) 
CHILLS † 1   
# participants affected / at risk   9/132 (6.82%) 
PAIN † 1   
# participants affected / at risk   7/132 (5.30%) 
Infections and infestations   
FOLLICULITIS † 1   
# participants affected / at risk   12/132 (9.09%) 
UPPER RESPIRATORY TRACT INFECTION † 1   
# participants affected / at risk   8/132 (6.06%) 
NASOPHARYNGITIS † 1   
# participants affected / at risk   7/132 (5.30%) 
Injury, poisoning and procedural complications   
SUNBURN † 1   
# participants affected / at risk   19/132 (14.39%) 
Investigations   
GAMMA-GLUTAMYLTRANSFERASE INCREASED † 1   
# participants affected / at risk   17/132 (12.88%) 
BLOOD ALKALINE PHOSPHATASE INCREASED † 1   
# participants affected / at risk   10/132 (7.58%) 
ALANINE AMINOTRANSFERASE INCREASED † 1   
# participants affected / at risk   8/132 (6.06%) 
ASPARTATE AMINOTRANSFERASE INCREASED † 1   
# participants affected / at risk   7/132 (5.30%) 
BLOOD CREATININE INCREASED † 1   
# participants affected / at risk   12/132 (9.09%) 
LYMPHOCYTE COUNT DECREASED † 1   
# participants affected / at risk   7/132 (5.30%) 
BLOOD BILIRUBIN INCREASED † 1   
# participants affected / at risk   7/132 (5.30%) 
WEIGHT DECREASED † 1   
# participants affected / at risk   12/132 (9.09%) 
Metabolism and nutrition disorders   
DECREASED APPETITE † 1   
# participants affected / at risk   28/132 (21.21%) 
HYPOKALAEMIA † 1   
# participants affected / at risk   10/132 (7.58%) 
HYPERGLYCAEMIA † 1   
# participants affected / at risk   7/132 (5.30%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA † 1   
# participants affected / at risk   86/132 (65.15%) 
MYALGIA † 1   
# participants affected / at risk   31/132 (23.48%) 
MUSCULOSKELETAL PAIN † 1   
# participants affected / at risk   15/132 (11.36%) 
BACK PAIN † 1   
# participants affected / at risk   14/132 (10.61%) 
ARTHRITIS † 1   
# participants affected / at risk   12/132 (9.09%) 
PAIN IN EXTREMITY † 1   
# participants affected / at risk   12/132 (9.09%) 
JOINT SWELLING † 1   
# participants affected / at risk   7/132 (5.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MELANOCYTIC NAEVUS † 1   
# participants affected / at risk   7/132 (5.30%) 
Nervous system disorders   
HEADACHE † 1   
# participants affected / at risk   36/132 (27.27%) 
DYSGEUSIA † 1   
# participants affected / at risk   14/132 (10.61%) 
NEUROPATHY PERIPHERAL † 1   
# participants affected / at risk   13/132 (9.85%) 
DIZZINESS † 1   
# participants affected / at risk   8/132 (6.06%) 
Psychiatric disorders   
DEPRESSION † 1   
# participants affected / at risk   11/132 (8.33%) 
INSOMNIA † 1   
# participants affected / at risk   9/132 (6.82%) 
ANXIETY † 1   
# participants affected / at risk   7/132 (5.30%) 
Respiratory, thoracic and mediastinal disorders   
COUGH † 1   
# participants affected / at risk   16/132 (12.12%) 
OROPHARYNGEAL PAIN † 1   
# participants affected / at risk   13/132 (9.85%) 
DYSPNOEA † 1   
# participants affected / at risk   10/132 (7.58%) 
Skin and subcutaneous tissue disorders   
RASH † 1   
# participants affected / at risk   68/132 (51.52%) 
PHOTOSENSITIVITY REACTION † 1   
# participants affected / at risk   65/132 (49.24%) 
ALOPECIA † 1   
# participants affected / at risk   47/132 (35.61%) 
PRURITUS † 1   
# participants affected / at risk   40/132 (30.30%) 
SKIN PAPILLOMA † 1   
# participants affected / at risk   39/132 (29.55%) 
HYPERKERATOSIS † 1   
# participants affected / at risk   37/132 (28.03%) 
RASH MACULO-PAPULAR † 1   
# participants affected / at risk   27/132 (20.45%) 
ACTINIC KERATOSIS † 1   
# participants affected / at risk   22/132 (16.67%) 
DRY SKIN † 1   
# participants affected / at risk   21/132 (15.91%) 
RASH PAPULAR † 1   
# participants affected / at risk   17/132 (12.88%) 
KERATOSIS PILARIS † 1   
# participants affected / at risk   12/132 (9.09%) 
ERYTHEMA † 1   
# participants affected / at risk   11/132 (8.33%) 
PALMAR-PLANTAR † 1   
# participants affected / at risk   11/132 (8.33%) 
ERYTHRODYSAESTHESIA SYNDROME ACNE † 1   
# participants affected / at risk   10/132 (7.58%) 
DERMATITIS ACNEIFORM † 1   
# participants affected / at risk   9/132 (6.82%) 
SKIN EXFOLIATION † 1   
# participants affected / at risk   8/132 (6.06%) 
SKIN LESION † 1   
# participants affected / at risk   8/132 (6.06%) 
SEBORRHOEIC KERATOSIS † 1   
# participants affected / at risk   19/132 (14.39%) 
ACNE † 1   
# participants affected / at risk   10/132 (7.58%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0



  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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