Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

Mirati Therapeutics Inc.49 enrolled

Overview

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Malignancies

Interventions

SitravatinibDRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.

NivolumabDRUG

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

PembrolizumabDRUG

Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, United States

Local Institution - 516-014-029

Goshen, Indiana, United States

Local Institution - 516-014-002

Outcomes

Primary Outcomes

Number of Participants With Treatment Related Adverse Events.

An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.

Time frame: Approximately up to 80.5 weeks

Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation

Number of participants with treatment related adverse events which lead to study drug discontinuation.

Time frame: Approximately up to 80.5 weeks

Number of Participants With Clinically Significant Laboratory Abnormalities

An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE.

Time frame: Approximately up to 80.5 weeks

Data from ClinicalTrials.gov

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