NCT06640361

A Study of Olverembatinib in SDH-deficient GIST.

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.

Conditions

• GIST

Interventions

Type	Name	Description
DRUG	Olverembatinib	Oral administration with meal, QOD, every 28 days for a cycle.

Timeline

• Start date: 2024-11-11
• Primary completion: 2027-03-31
• Completion: 2029-06-30
• First posted: 2024-10-15
• Last updated: 2024-12-27

Locations

1 site across 1 country: China