PK Study to Assess Drug-drug Interaction Between Sitravatinib and a Cocktail of Substrates
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Two Part, Phase enrolling patients with advanced tumor types. All patients receive the same treatment.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Part 1 of this study is designed to evaluate the potential for drug-drug interactions 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) transpo...
Part 1 of this study is designed to evaluate the potential for drug-drug interactions 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.
Tracking Information
- NCT #
- NCT04887194
- Collaborators
- Not Provided
- Investigators
- Study Director: Curtis Chin, MD Mirati Therapeutics Inc.
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