Status:
TERMINATED
Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
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 melan...
Eligibility Criteria
Inclusion
- Age \>18 years old.
- Histologic proof of melanoma reviewed and confirmed by MSKCC.
- A confirmed EBRAFV600E or KBRAFV600K mutation.
- Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study.
- Measurable disease by RECIST v1.1.
- ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed \> 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2).
- Patients must be able to swallow pills
- Adequate hematologic, hepatic and renal function as defined by the following:
- Absolute Neutrophil Count ≥ 1.0 x 109/L
- Hemoglobin ≥8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities.
- Total bilirubin ≤2.0x the upper limit of normal, ≤3.0x the upper limit of normal if the patient has Gilbert's Syndrome.
- Alkaline phosphatase ≤2.0x the upper limit of normal.
- AST and ALT ≤2.0x the upper limit of normal.
- Serum creatinine ≤ 1.5x the upper limit of normal.
Exclusion
- Uveal melanoma as primary.
- Concurrent chemotherapy, immunotherapy, or radiotherapy.
- Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies.
- Pregnant or lactating women.
- A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible.
- QTc interval \> 500 msec.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01474551
Start Date
November 1 2011
End Date
March 1 2013
Last Update
November 18 2015
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065