Actively Recruiting
Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients
Led by Asan Medical Center · Updated on 2026-04-03
48
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to evaluate the safety and efficacy of lenvatinib in patients with metastatic or advanced GIST who have failed at least imatinib, sunitinib, and regorafenib treatment.
CONDITIONS
Official Title
Lenvatinib After Progression on Imatinib, Sunitinib, and Regorafenib for GIST Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at time of consent
- Histologically confirmed metastatic or advanced GIST with CD117(+), DOG-1(+), or mutations in KIT or PDGFRα genes
- Documented failure of prior imatinib, sunitinib, and regorafenib due to disease progression or intolerance
- ECOG performance status of 0 to 2
- Recovery from previous treatment toxicities to Grade 0 or 1 per NCI-CTCAE version 5.0
- At least one measurable lesion by mRECIST version 1.1
- Adequate bone marrow, liver, kidney, and other organ function
- Life expectancy of at least 12 weeks
- Required washout periods from previous treatments before enrollment
- Signed written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women of childbearing potential
- Unwillingness to use effective contraception during and for 6 months after treatment
- Need to use barrier contraception during treatment and for 1 month after final dose
- Women of childbearing potential defined by recent menstruation or lack of hysterectomy
- History within 6 months of serious cardiovascular events or conditions
- Uncontrolled active infections
- Diabetes with significant peripheral vascular disease
- Acute or chronic liver disease (except stable chronic hepatitis B)
- Uncontrolled gastrointestinal toxicities above Grade 2
- Severe acute or chronic medical or psychiatric conditions that increase study risk
- Recent life-threatening or severe bleeding events within 3 months
- Use of systemic anticoagulants or antithrombotics within 7 days prior to consent (aspirin allowed up to 325 mg/day)
- Uncontrolled hypertension not well managed with medication
- Major surgery, significant trauma, or non-healed wounds within 3 weeks prior to consent
- Significant cardiovascular or vascular conditions within 6 months prior to consent
- Clinically significant kidney diseases
- Known HIV infection
- Recent or active other primary malignancies requiring treatment
- Evidence of brain metastasis with central nervous system symptoms
- History of alcohol or substance abuse disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
J
Jaewon Hyung
CONTACT
H
Hyung-Don kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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