Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- overall objective response [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- effects of clinical benefit [ Time Frame: 2 years ] [ Designated as safety issue: No ]i.e. improvement in performance and functional status). The effects on clinical benefit (changes in ECOG performance status, timed "up and go", Katz score of ADLs, and achievement of personal aspiration) will be reported but no formal statistical analysis is planned.
- Time to progression and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Time to progression and overall survival will be estimated using Kaplan-Meier methodology.
- To assess toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]All adverse events encountered during the study will be evaluated according to the NCI Common Toxicity Grading system version 4.0.
|Study Start Date:||November 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|