Clinical Trial VICCMEL1168
Title
An Open-label Multicenter Phase II Study of Continuous Oral Vemurafenib in Patients with Locally-Advanced, Unresectable, Stage IIIC or Metastatic Melanoma and Activating Exon 15 BRAF mutations other than V600E
Principal Investigator(s)
Details
- Protocol No. VICCMEL1168
- Open Date: 07/12/2012
- Staging: Phase II
- Age Group: Both Child and Adult
- Scope: National
- Objective: To determine the investigator-assessed best objective response rate (BORR) (according to Response Evaluation Criteria in Solid Tumors, version 1.1 [RECIST, v1.1]) for vemurafenib treatment in patients with metastatic melanoma who have an activating BRAF mutation detected by DNA sequencing, but a negative cobas? 4800 BRAF V600 Mutation Test result, and who are otherwise without satisfactory treatment option.
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: PLX4032; RO5185426 (Vemurafenib); Vemurafenib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01586195
- Secondary Protocol No: ML27763
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 16 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2
• Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E
• Measurable disease (as defined by RECIST, v1.1)
• Adequate recovery from most recent systemic or local treatment for cancer
• Adequate organ function
• Women of childbearing potential and male partners of women of childbearing potential: agreement to use prescribed contraception.
• Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
• Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of vemurafenib; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib
Exclusion Criteria:
• Invasive malignancy other than melanoma at the time of enrollment and within 2 years prior
• Pregnant or breast-feeding
• Concurrent anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, including participation in an experimental drug study)
• Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
• Ongoing cardiac dysrhythmia >/= Grade 2
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