Status:
TERMINATED
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Plexxikon
Conditions:
V600-mutated BRAF Unresectable Melanoma
V600-mutated BRAF Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has b...
Eligibility Criteria
Inclusion
- Male or female ≥18 years old.
- Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.
- Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.
- Measurable disease per RECIST v. 1.1 criteria.
- ECOG performance status 0 or 1.
Exclusion
- Radiation therapy within 14 days of C1D1.
- Investigational drug use within 28 days of C1D1.
- Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.
Key Trial Info
Start Date :
November 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01826448
Start Date
November 5 2013
End Date
September 22 2014
Last Update
May 28 2020
Active Locations (6)
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1
UCLA
Los Angeles, California, United States, 90024
2
University of Colorado, Denver
Aurora, Colorado, United States, 80012
3
Vanderbilt University
Nashville, Tennessee, United States, 37232
4
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109