GIST
Conditions
Keywords
Olverembatinib, GIST
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.
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.
Interventions
DRUGOlverembatinib
Oral administration with meal, QOD, every 28 days for a cycle.
Sponsors
Ascentage Pharma Group Inc.
HealthQuest Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) rate | 36 months | Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of olverembatinib | Cycle 2 to Cycle 3 (each cycle is 28 days) | Blood samples will be collected to measure the plasma concentration of olverembatinib. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Through study completion,an average of 2 years. | According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed. |
Countries
China
Contacts
CONTACTYifan Zhai, M.D., Ph.D.
CONTACTChen Yang, M.D.
STUDY_CHAIRRuihua Xu, M.D., Ph.D.
Sun Yat-Sen University Cancer Center
Outcome results
None listed