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

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ClinicalTrials.gov Identifier: NCT01826448
Recruitment Status : Terminated (No activity was observed. BRAFi-naïve participants should have received triple combination treatment (including MEK inhibitor). Continuation was not justified.)
First Posted : April 8, 2013
Results First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Plexxikon
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: PLX3397 Drug: vemurafenib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2013
Actual Primary Completion Date : September 22, 2014
Actual Study Completion Date : September 22, 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Vemurafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose extension cohort
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.
 Drug: PLX3397
Drug: vemurafenib
Other Name: Zelboraf
Experimental: Cohort 3
Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
 Drug: PLX3397
Drug: vemurafenib
Other Name: Zelboraf
Experimental: Cohort 2
Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
 Drug: PLX3397
Drug: vemurafenib
Other Name: Zelboraf
Experimental: Cohort 1
Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
 Drug: PLX3397
Drug: vemurafenib
Other Name: Zelboraf


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826448


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90024
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80012
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
France
Institute Gustave Roussy
Paris, France
Germany
University Hospital Essen
Essen, Germany
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Plexxikon
More Information
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01826448    
Other Study ID Numbers: PLX108-09
First Posted: April 8, 2013    Key Record Dates
Results First Posted: May 28, 2020
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Vemurafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action