At a glance
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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
In Brief
A Phase 1 clinical trial evaluating losartan, dextromethorphan, and 8 other interventions for Advanced Solid Tumors and Metastatic Melanoma. Completed, enrolled 56 participants across 29 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
taken orally
taken orally
taken orally
taken orally
taken orally
taken orally
taken orally
taken orally
taken orally
taken orally