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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |

Arm | Intervention/treatment |
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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.
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Drug: PLX3397 Drug: vemurafenib Other Name: Zelboraf |
Experimental: Cohort 3
Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
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Drug: PLX3397 Drug: vemurafenib Other Name: Zelboraf |
Experimental: Cohort 2
Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
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Drug: PLX3397 Drug: vemurafenib Other Name: Zelboraf |
Experimental: Cohort 1
Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
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Drug: PLX3397 Drug: vemurafenib Other Name: Zelboraf |
- Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma [ Time Frame: 1 year ]

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

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
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 |
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/ |
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