Clareo Health | Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Genentech, Inc.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
