Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Advanced Solid Tumors, Metastatic Melanoma
In brief
This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.
Key facts
- Study ID
- NCT03864042
- Run by
- Pfizer
- People needed
- 56
- Starts
- 2018-01-02
- Expected to finish
- 2023-05-29
- Last updated by the study team
- 2024-09-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UC Irvine Health — Orange, California, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
- Hopkins Eye Clinic — Hopkins, Minnesota, United States
- Park Nicollet Eye Clinic — Maple Grove, Minnesota, United States
- Regions Cancer Care Center — Saint Paul, Minnesota, United States
- HealthPartners Specialty Center-Eye Care — Saint Paul, Minnesota, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- University of TN Medical Center — Knoxville, Tennessee, United States
- Mary Crowley Cancer Research - Medical City Hospital — Dallas, Texas, United States
- Utah Cancer Specialists — West Valley City, Utah, United States
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium
- Cross Cancer Institute — Edmonton, Alberta, Canada
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- Sir Mortimer B Davis Jewish General Hospital — Montreal, Quebec, Canada
- McGill University Health Center — Montreal, Quebec, Canada
- Jewish General Hospital — Montrea, Quebec, Canada
- Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands
- Erasmus Medical Center — Rotterdam, Netherlands
- Hospital del Mar — Barcelona, Spain
- Hospital Clinico Universitario Virgen de la Arrixaca — El Palmar, Spain
- Hospital Universitari Arnau de Vilanova — Lleida, Spain
- Hospital Beata Maria Ana — Madrid, Spain
- Hospital General Universitario Gregorio Marañon — Madrid, Spain
- Clinica Rementeria — Madrid, Spain
Full record on ClinicalTrials.gov
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