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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


Phase 1
18 Years
N/A
Not Enrolling
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

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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 AllianceSeattle, Washington  98109
Vanderbilt UniversityNashville, Tennessee  37232-6305
UCLALos Angeles, California  90095
University of Colorado, DenverAurora, Colorado  80045