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


  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  
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%)  
KERATOSIS PILARIS † 1  
# participants affected / at risk     12/132 (9.09%)  
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%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949702     History of Changes
Other Study ID Numbers: NP22657
Study First Received: July 28, 2009
Results First Received: July 29, 2011
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration