Spots Global Cancer Trial Database for Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
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Trial Identification
Brief Title: Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Official Title: An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors
Study ID: NCT03864042
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC, Madrid, , Spain
CERCO, Sevilla, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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