NCT04887194

PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

A Two-cohort, Two-part, Phase 1, Multicenter, Open-label, Fixed-sequence, Drug-Drug Interaction and QTc Assessments of Sitravatinib Followed by Combination Treatment With Nivolumab in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Detailed description

Part 1 of this study is designed to evaluate the potential for drug-drug interactions and QTc effects with sitravatinib monotherapy when administered with probe drugs for specific cytochrome P450 (CYP) enzymes (CYP2C9, CYP2D6, and CYP3A4) and P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters Part 2 allows for patients to continue sitravatinib treatment with the addition of the checkpoint inhibitor Nivolumab.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Sitravatinib	Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
DRUG	Warfarin	CYP2C9 probe substrate
DRUG	Dextromethorphan	CYP2D6 probe substrate
DRUG	Midazolam	CYP3A4 probe substrate
DRUG	Digoxin	P-gp probe substrate
DRUG	Rosuvastatin	BCRP probe substrate
DRUG	Nivolumab	Nivolumab is a programmed death receptor (PD-1) blocking antibody

Timeline

• Start date: 2021-04-08
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2021-05-14
• Last updated: 2024-05-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study