Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation
NCT ID: NCT01474551
Last Updated: 2015-11-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2011-11-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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vemurafenib
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
19 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Paul Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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Alloo A, Garibyan L, LeBoeuf N, Lin G, Werchniak A, Hodi FS Jr, Flaherty KT, Lawrence DP, Lin JY. Photodynamic therapy for multiple eruptive keratoacanthomas associated with vemurafenib treatment for metastatic melanoma. Arch Dermatol. 2012 Mar;148(3):363-6. doi: 10.1001/archdermatol.2011.3080.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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11-091
Identifier Type: -
Identifier Source: org_study_id