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Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

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ClinicalTrials.gov Identifier: NCT01474551
Recruitment Status : Terminated (Lack of accrual)
First Posted : November 18, 2011
Results First Posted : April 30, 2015
Last Update Posted : November 18, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: vemurafenib
Enrollment 2
Recruitment Details Protocol Open to Accrual: 11/15/2011 Protocol Closed to Accrual: 03/12/2013 Primary Completion Date (if applicable): 03/12/2013 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Vemurafenib
Hide Arm/Group Description

This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Vemurafenib
Hide Arm/Group Description

This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Overall Objective Response
Hide Description The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vemurafenib
Hide Arm/Group Description:

This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
Stable Disease 1
Complete Response 0
Partial Response 0
Progression of Disease 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vemurafenib
Hide Arm/Group Description

This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.

All-Cause Mortality
Vemurafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vemurafenib
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
General disorders   
Death NOS  1  1/2 (50.00%)  1
Investigations   
Creatinine increase  1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hyperkalemia  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vemurafenib
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Investigations   
Blood bilirubin increased  1  1/2 (50.00%)  1
Creatinine increased  1  1/2 (50.00%)  3
INR increased  1  1/2 (50.00%)  1
Lymphocyte count decreased  1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/2 (50.00%)  8
Hyperkalemia  1  1/2 (50.00%)  1
Hypoalbuminemia  1  1/2 (50.00%)  14
Hypocalcemia  1  1/2 (50.00%)  1
Hyponatremia  1  1/2 (50.00%)  6
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paul Chapman
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4162
EMail: chapmanp@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01474551     History of Changes
Other Study ID Numbers: 11-091
First Submitted: November 15, 2011
First Posted: November 18, 2011
Results First Submitted: April 15, 2015
Results First Posted: April 30, 2015
Last Update Posted: November 18, 2015