Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
- Conditions
- Advanced or Metastatic Solid Malignancies
- Interventions
- Registration Number
- NCT04887870
- Lead Sponsor
- Mirati Therapeutics Inc.
- Brief Summary
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
- Detailed Description
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.
The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 55
- Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
- Currently tolerating the treatment regimen in the parent protocol
- Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
- Known or suspected presence of other cancer
- Other life- threatening illness or organ system dysfunction compromising safety evaluation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 2/3: Open label extension of parent study Enfortumab Vedotin-Ejfv The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. Phase 2/3: Open label extension of parent study Sitravatinib The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. Phase 2/3: Open label extension of parent study Nivolumab The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. Phase 2/3: Open label extension of parent study Pembrolizumab The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. Phase 2/3: Open label extension of parent study Ipilimumab The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
- Primary Outcome Measures
Name Time Method Frequency of subjects experiencing treatment-related AEs. 24 Months Frequency of subjects experiencing treatment-related AEs.
- Secondary Outcome Measures
Name Time Method Time to clinical or radiographic progression on study. 24 Months Time to clinical or radiographic progression on study.
Trial Locations
- Locations (13)
Local Institution - 516-014-004
🇺🇸Columbus, Ohio, United States
Local Institution - 516-014-011
🇺🇸Albany, New York, United States
Local Institution - 516-014-027
🇺🇸Fairfax, Virginia, United States
Local Institution - 516-014-005
🇺🇸Minneapolis, Minnesota, United States
Local Institution - 516-014-013
🇺🇸Houston, Texas, United States
Local Institution - 516-014-029
🇺🇸Goshen, Indiana, United States
Local Institution - 516-014-021
🇺🇸Littleton, Colorado, United States
Local Institution - 516-014-002
🇺🇸Boston, Massachusetts, United States
Local Institution - 516-014-016
🇺🇸New York, New York, United States
Local Institution - 516-014-006
🇺🇸Denison, Texas, United States
Local Institution - 516-014-001
🇺🇸Austin, Texas, United States
Local Institution - 516-014-014
🇺🇸Detroit, Michigan, United States
Local Institution - 516-014-018
🇺🇸Omaha, Nebraska, United States