A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:June 2013
Contact:Henry Hsu, MD
Email:hhsu@plexxikon.com

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A Phase 1b Open Label, Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma

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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
4
sites
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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