Study Stopped
No activity was observed. BRAFi-naïve participants should have received triple combination treatment (including MEK inhibitor). Continuation was not justified.
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
1 other identifier
interventional
13
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2013
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedStudy Start
First participant enrolled
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2014
CompletedResults Posted
Study results publicly available
May 28, 2020
CompletedMay 28, 2020
May 1, 2020
11 months
April 1, 2013
May 12, 2020
May 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
1 year
Study Arms (4)
Dose extension cohort
EXPERIMENTALPatients 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
EXPERIMENTALPatients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
Cohort 2
EXPERIMENTALPatients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
Cohort 1
EXPERIMENTALPatients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Plexxikoncollaborator
Study Sites (6)
UCLA
Los Angeles, California, 90024, United States
University of Colorado, Denver
Aurora, Colorado, 80012, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Institute Gustave Roussy
Paris, France
University Hospital Essen
Essen, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated due to business decision before the planned sample size was reached; therefore, the planned outcome measure cannot be evaluated.
Results Point of Contact
- Title
- Medical Director
- Organization
- Daiichi Sankyo Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 8, 2013
Study Start
November 5, 2013
Primary Completion
September 22, 2014
Study Completion
September 22, 2014
Last Updated
May 28, 2020
Results First Posted
May 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/