Clinical trial NCT04887870: Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
Official title: A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Advanced or Metastatic Solid Malignancies
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known or suspected presence of other cancer
* Other life- threatening illness or organ system dysfunction compromising safety evaluation

Primary outcomes:
measure: Frequency of subjects experiencing treatment-related AEs.
timeFrame: 24 Months
Secondary outcomes:
measure: Time to clinical or radiographic progression on study.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Littleton
country: United States
facility: Local Institution - 516-014-021
state: Colorado
city: Goshen
country: United States
facility: Local Institution - 516-014-029
state: Indiana
city: Boston
country: United States
facility: Local Institution - 516-014-002
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 516-014-014
state: Michigan
city: Minneapolis
country: United States
facility: Local Institution - 516-014-005
state: Minnesota
city: Omaha
country: United States
facility: Local Institution - 516-014-018
state: Nebraska
city: Albany
country: United States
facility: Local Institution - 516-014-011
state: New York
city: New York
country: United States
facility: Local Institution - 516-014-016
state: New York
city: Columbus
country: United States
facility: Local Institution - 516-014-004
state: Ohio
city: Austin
country: United States
facility: Local Institution - 516-014-001
state: Texas
city: Denison
country: United States
facility: Local Institution - 516-014-006
state: Texas
city: Houston
country: United States
facility: Local Institution - 516-014-013
state: Texas
city: Fairfax
country: United States
facility: Local Institution - 516-014-027
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: