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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Dextromethorphan; Digoxin; Midazolam; Nivolumab; Rosuvastatin Calcium; Warfarin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of unresectable advanced/metastatic solid tumor

• Life expectancy of at least 3 months

• Adequate bone marrow and organ function

Exclusion Criteria:

• Ongoing medical condition or need for treatment with medication that may affect the PK of study treatments during Part 1

• Immunocompromising conditions

• Impaired heart function

• Active or prior documented autoimmune disease