Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
Study Details
Study Description
Brief Summary
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Phase 2/3: Open label extension of parent study 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. |
Drug: Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Names:
Drug: Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Names:
Drug: Pembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
Other Names:
Drug: Enfortumab Vedotin-Ejfv
Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
Other Names:
Drug: Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Frequency of subjects experiencing treatment-related AEs. [24 Months]
Frequency of subjects experiencing treatment-related AEs.
Secondary Outcome Measures
- Time to clinical or radiographic progression on study. [24 Months]
Time to clinical or radiographic progression on study.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
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Currently tolerating the treatment regimen in the parent protocol
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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
Exclusion Criteria:
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Known or suspected presence of other cancer
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Other life- threatening illness or organ system dysfunction compromising safety evaluation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beverly Hills Cancer Center | Beverly Hills | California | United States | 90211 |
2 | Rocky Mountain Cancer Centers | Aurora | Colorado | United States | 90012 |
3 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
4 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
5 | University of Minnesota Health Clinics and Surgery Center | Minneapolis | Minnesota | United States | 55455 |
6 | GU Research Network/Urology Cancer Center | Omaha | Nebraska | United States | 68130 |
7 | New York Oncology Hematology, P.C. | Clifton Park | New York | United States | 12065 |
8 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
9 | The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic | Columbus | Ohio | United States | 43210 |
10 | Texas Oncology - Denison Cancer Center | Denison | Texas | United States | 75020 |
11 | UT MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
12 | NEXT Oncology | San Antonio | Texas | United States | 78229 |
13 | NEXT Virginia | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Mirati Therapeutics Inc.
Investigators
- Study Director: Ronald Shazer, MD, Mirati Therapeutics Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 516-014