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
18 Years
N/A
Both
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
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety-Subject incidence of adverse events
Outcome Description:
Subjects will take oral doses of PLX3397 and vemurafenib twice a day. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology and serum chemistry will be used to assess safety throughout the study. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
Outcome Time Frame:
1 year
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
PLX108-09
NCT ID:
NCT01826448
Start Date:
June 2013
Completion Date:
Related Keywords:
- 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
- Melanoma
Name | Location |
|---|---|
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Vanderbilt University | Nashville, Tennessee 37232-6305 |
| UCLA | Los Angeles, California 90095 |
| University of Colorado, Denver | Aurora, Colorado 80045 |
