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

Phase 1

Terminated

• Conditions: 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
• Interventions: Drug: PLX3397; Drug: vemurafenib

• Registration Number: NCT01826448
• Lead Sponsor: Daiichi Sankyo

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Study Start: 2013-11-05
• Primary Completion: 2014-09-22
• Study Completion: 2014-09-22
• Status Verified: 2020-05
• Results First Submitted: 2020-05-12
• Results First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Results First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 2	PLX3397	Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
Dose extension cohort	PLX3397	Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts.
Dose extension cohort	vemurafenib	Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts.
Cohort 3	PLX3397	Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
Cohort 1	PLX3397	Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
Cohort 3	vemurafenib	Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
Cohort 1	vemurafenib	Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
Cohort 2	vemurafenib	Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma	1 year

Trial Locations

Locations (6)

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Institute Gustave Roussy; 🇫🇷 Paris, France

University Hospital Essen; 🇩🇪 Essen, Germany