RecruitingPhase 3NCT06640361

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)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

40 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Olverembatinib for people with gist. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlverembatinib

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


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06640361


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