Olverembatinib for treating SDH-deficient GIST

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international multicenter phase III study evaluates the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumors (GIST) who have previously undergone one line of therapy. Participants will receive olverembatinib tablets at a dosage of 40mg, taken orally with meals every other day for a 28-day cycle. The study aims to assess progression-free survival and the clinical benefit rate of the treatment in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Must have at least one measurable target lesion.
3. ECOG≤ 2.
4. Expected survival of at least 3 months.
5. Adequate organ function.
6. Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dose of study drug.
7. Males, women of childbearing potential, as well as their partners, voluntarily take effective contraceptive measures as specified in the protocol from the time of signing the informed consent form until at least 30 days after the last dose of study drug.
8. Prior to initiation of any screening or study-specific procedures, the patient or his/her guardian is able to understand and voluntarily sign an informed consent form approved by the Ethics Committee in writing, voluntarily and able to complete the study procedures and follow-up examinations.

Exclusion Criteria:

1. Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.
2. Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
3. Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
4. Adverse events due to prior treatment have not recovered (\> NCI CTCAE v5.0 Grade 1).
5. Absorption disorder syndrome or other conditions that affect the absorption of oral medications.
6. With clinically significant, uncontrolled or active cardiovascular disease or thrombotic disease.
7. Poorly controlled hypertension after hypertension medication.
8. Severe cardiovascular and cerebrovascular diseases during previous use of TKIs.
9. Uncontrolled Hyperlipidemia.
10. Major surgery, open biopsy, or major traumatic injury within 14 days prior to initiation of study drug.
11. With brain metastases.
12. Other malignancies within 2 years.
13. Uncontrolled systemic active fungal, bacterial, and/or viral infections.
14. Female patients who are pregnant or lactating, or female patients who are expecting to become pregnant within the period of this study.
15. Any symptoms or disease of the patient, in the judgment of the investigator or sponsor, that may jeopardize their safety or interfere with the safety evaluation of the investigational drug.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yifan Zhai, M.D., Ph.D.
• Email: yzhai@ascentage.com
• Phone: +86-20-28068501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KQB198 plus imatinib for first-line advanced or metastatic GIST

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• How olverembatinib is processed in people with liver impairment

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• Lenvatinib for advanced GIST after imatinib, sunitinib, and regorafenib

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• ThisCART19A plus Olverembatinib for newly diagnosed Ph+ ALL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.