Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
|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
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: vemurafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center Phase II Trial of Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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.
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 Objective Response [ Time Frame: 2 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474551
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Paul Chapman, MD||Memorial Sloan Kettering Cancer Center|