Status:
COMPLETED
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of unresectable advanced/metastatic solid tumor
- Life expectancy of at least 3 months
- Adequate bone marrow and organ function
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04887194
Start Date
April 8 2021
End Date
December 22 2022
Last Update
May 8 2024
Active Locations (5)
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1
Goshen Health
Goshen, Indiana, United States, 46526
2
NEXT Oncology
Austin, Texas, United States, 78758
3
NEXT Oncology
San Antonio, Texas, United States, 78229
4
NEXT Oncology
Fairfax, Virginia, United States, 22031