Brief 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.
Intervention / Treatment
- Drug: Olverembatinib
Inclusion Criteria:
- 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.
- Must have at least one measurable target lesion.
- ECOG≤ 2.
- Expected survival of at least 3 months.
- Adequate organ function.
- Negative serum pregnancy test result for women of childbearing potential within 7 days prior to taking the first dosethe amount of medication taken of study drug.
- 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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form until at least 30 days after the last dose of study drug.
- Prior to initiation of any screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.