NCT03864042

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	losartan	taken orally
DRUG	dextromethorphan	taken orally
DRUG	caffeine	taken orally
DRUG	omeprazole	taken orally
DRUG	midazolam	taken orally
DRUG	rosuvastatin	taken orally
DRUG	bupropion immediate release (IR)	taken orally
DRUG	encorafenib	taken orally
DRUG	binimetinib	taken orally
DRUG	modafinil	taken orally

Timeline

• Start date: 2018-01-02
• Primary completion: 2022-07-11
• Completion: 2023-05-29
• First posted: 2019-03-06
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

29 sites across 5 countries: United States, Belgium, Canada, Netherlands, Spain

Regulatory

• FDA-regulated drug study