Actively Recruiting
A Study of Olverembatinib in SDH-deficient GIST.
Led by Ascentage Pharma Group Inc. · Updated on 2024-12-27
40
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
H
HealthQuest Pharma Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Olverembatinib in SDH-deficient GIST.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed GIST with loss of SDHB expression and failure of at least one prior systemic therapy
- At least one measurable target lesion
- ECOG performance status of 0 to 2
- Expected survival time of at least 3 months
- Adequate organ function
- Negative pregnancy test for women of childbearing potential within 7 days before first dose
- Effective contraceptive use by males, women of childbearing potential, and their partners from consent until 30 days after last dose
- Ability to understand and voluntarily sign informed consent and complete study procedures and follow-up
You will not qualify if you...
- Receipt of chemotherapy, radiotherapy, biologic therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life before first dose
- Tyrosine kinase inhibitor therapy within 7 days before first dose
- Use of drugs interacting with study drug within 7 days before first dose
- Ongoing adverse events from prior treatment above Grade 1 (NCI CTCAE v5.0)
- Conditions affecting oral medication absorption
- Uncontrolled or active cardiovascular or thrombotic disease
- Poorly controlled hypertension despite medication
- Severe cardiovascular or cerebrovascular disease during prior TKI use
- Uncontrolled hyperlipidemia
- Major surgery, open biopsy, or major trauma within 14 days before study drug
- Presence of brain metastases
- Other cancers within past 2 years
- Uncontrolled systemic infections
- Pregnancy or lactation
- Any condition judged by investigator to risk safety or interfere with drug evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
C
Chen Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here