A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Stopped early · Phase 1
Conditions studied: V600-mutated BRAF Unresectable Melanoma, V600-mutated BRAF Metastatic Melanoma, Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
In brief
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 been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
Key facts
- Study ID
- NCT01826448
- Run by
- Daiichi Sankyo
- People needed
- 13
- Starts
- 2013-11-05
- Expected to finish
- 2014-09-22
- Last updated by the study team
- 2020-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCLA — Los Angeles, California, United States
- University of Colorado, Denver — Aurora, Colorado, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Institute Gustave Roussy — Paris, France
- University Hospital Essen — Essen, Germany
Full record on ClinicalTrials.gov
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