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Trial Title:
A Study of Olverembatinib in SDH-deficient GIST.
NCT ID:
NCT06640361
Condition:
GIST
Conditions: Keywords:
Olverembatinib
GIST
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olverembatinib
Description:
Oral administration with meal, QOD, every 28 days for a cycle.
Arm group label:
Olverembatinib
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Ruihua Xu, M.D.,Ph.D.
Phone:
020-87343468
Email:
xurh@sysucc.org.cn
Investigator:
Last name:
Ruihua Xu, M.D.,Ph.D.
Email:
Principal Investigator
Start date:
October 2024
Completion date:
June 30, 2029
Lead sponsor:
Agency:
Ascentage Pharma Group Inc.
Agency class:
Industry
Collaborator:
Agency:
HealthQuest Pharma Inc.
Agency class:
Industry
Source:
Ascentage Pharma Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06640361
