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 |
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Recruitment Status :
Terminated
First Posted : April 8, 2013
Last Update Posted : September 29, 2014
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Sponsor:
Plexxikon
Information provided by (Responsible Party):
Plexxikon
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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 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 |
| Study Start Date : | June 2013 |
| Actual Primary Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Melanoma
Drug Information available for:
Vemurafenib
| 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 |
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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 |
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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 |
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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 |
Primary Outcome Measures :
- Safety-Subject incidence of adverse events [ Time Frame: 1 year ]Subjects will take oral doses of PLX3397 and vemurafenib twice a day. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology and serum chemistry will be used to assess safety throughout the study. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.
- Overall response rate - for those patients taking PLX3397 and vemurafenib at the recommended phase 2 dose. [ Time Frame: 1 year ]Patients will have CT scans every 6 weeks for the first 12 weeks and every 9 weeks thereafter. Response to treatment will be evaluated using RECIST 1.1 criteria.
- Response Duration - for those patients taking PLX3397 and vemurafenib at the recommended phase 2 dose. [ Time Frame: 1 year ]CT scans will be taken every 6 weeks for the first 12 weeks and every 9 weeks thereafter. Response duration is defined as number of days from date of initial response to date of first documented disease progression or death, whichever occurs first.
- progression free survival (PFS)-for those patients taking PLX3397 and vemurafenib at the recommended phase 2 dose. [ Time Frame: 1 year ]CT scans will be taken every 6 weeks for the first 12 weeks and then every 9 weeks therafter. PFS will be calculated as the number of days from first day of treatment to date of first documented disease progression or date of death, whichever comes first.
- overall survival- for those patients taking PLX3397 and vemurafenib at the recommended phase 2 dose. [ Time Frame: 1 year ]Patients will be followed every 3 months for overall survival.
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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.
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
| 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
Plexxikon
| Responsible Party: | Plexxikon |
| ClinicalTrials.gov Identifier: | NCT01826448 History of Changes |
| Other Study ID Numbers: |
PLX108-09 |
| First Posted: | April 8, 2013 Key Record Dates |
| Last Update Posted: | September 29, 2014 |
| Last Verified: | September 2014 |
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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |