NCT04887870|CompletedPhase 2ResultsFDA Drug

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

A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies

Mirati Therapeutics Inc.ClinicalTrials.gov

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2 other identifiers

CA248-0003516-014

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMay 2021

StartedJun 2021

CompletionSep 2025

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jun 2021

Typical duration for phase_2

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.2 years study duration

First Submitted

Initial submission to the registry

April 28, 2021

Completed

16 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

June 29, 2021

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed

10 months until next milestone

Results Posted

Study results publicly available

August 4, 2026

Completed

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

3.8 years

First QC Date

April 28, 2021

Results QC Date

April 20, 2026

Last Update Submit

July 10, 2026

Conditions

Advanced or Metastatic Solid Malignancies

Outcome Measures

Primary Outcomes (3)

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.
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.
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.
Approximately up to 80.5 weeks

Study Arms (1)

Phase 2/3: Open label extension of parent study

EXPERIMENTAL

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: SitravatinibDrug: NivolumabDrug: PembrolizumabDrug: Enfortumab Vedotin-EjfvDrug: Ipilimumab