POLARIS-3: Olverembatinib in SDH-deficient GIST

 

Trial name: POLARIS-3
Agents: Olverembatinib
Phase III
Status Open, recruiting
Sponsor Ascentage

 

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

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Adult patients with histologically and/or cytologically confirmed GIST
  • Immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.
  • Overall health status of the patient has to be good (ECOG performance status 0, 1 or 2).
  • Expected survival of at least 3 months.

WHAT is the key question that this trial is attempting to answer?

 The primary objective of the trial is the progression free survival rate:

Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in GIST and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open for recruitment.

WHERE is the trial available?

 The trial is currently active in China. More sites/countries are following.

Please check for current information here.

Study contact and backup:

STUDY DESIGN: What does the study look like?

 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.

This study is not blinded. All patients receive the same treatment.

HOW do I get more information?

 Patient organizations supporting GIST and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken