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

Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01826448
• Other study ID #: PLX108-09
• Status: Terminated
• Phase: Phase 1
• Start date: November 5, 2013
• Est. completion date: September 22, 2014

Study information

• Verified date: May 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 22, 2014
• Est. primary completion date: September 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
• V600-mutated BRAF Metastatic Melanoma
• V600-mutated BRAF Unresectable Melanoma

Intervention

Drug:
• PLX3397

• vemurafenib

Locations

Country	Name	City	State
France	Institute Gustave Roussy	Paris
Germany	University Hospital Essen	Essen
United States	University of Colorado, Denver	Aurora	Colorado
United States	UCLA	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.	Plexxikon

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma		1 year