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RECRUITING
NCT06640361
PHASE3

A Study of Olverembatinib in SDH-deficient GIST.

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.

Official title: A Single-Arm Registrational Phase III Study of Olverembatinib in the Treatment of Patients With SDH-Deficient Gastrointestinal Stromal Tumor (POLARIS-3)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-11-11

Completion Date

2029-06-30

Last Updated

2024-12-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Olverembatinib

Oral administration with meal, QOD, every 28 days for a cycle.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China