Clinical Trial VICCMEL1256
Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of Vemurafenib (RO5185426) Adjuvant Therapy In Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma At High Risk For Recurrence
Principal Investigator(s)
Details
- Protocol No. VICCMEL1256
- Open Date: 12/06/2012
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To evaluate the efficacy of vemurafenib adjuvant treatment administered over a 52-week period in patients with completely resected BRAFV600 mutation positive, cutaneous melanoma, as measured by DFS
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: PLX4032; RO5185426 (Vemurafenib); Vemurafenib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01667419
- Secondary Protocol No: G027826
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Patients with completely resected, histologically confirmed, Stage IIC or Stage III, cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter
• Patients must have been surgically rendered free of disease within 70 days of randomization
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Life expectancy of at least 5 years
• Patients must have fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
• Adequate hematologic, hepatic and renal function
Exclusion Criteria:
• History of any systemic therapy for the treatment of melanoma
• History of limb perfusion therapy
• History of radiotherapy for the treatment of melanoma
• Invasive malignancy other than melanoma at the time of enrollment or within 3 years prior to first dose of study treatment
• Family history of colon cancer syndromes
• History of clinically significant cardiac or pulmonary dysfunction
• Major surgical procedure within 4 weeks prior to first dose of study treatment
• Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus
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