Actively Recruiting
Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
Led by Asan Medical Center · Updated on 2026-04-07
48
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of rivoceranib and paclitaxel combination therapy in patients with P-glycoprotein overexpressing GIST who failed standard treatment with imatinib, sunitinib, and regorafenib.
CONDITIONS
Official Title
Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at the time of consent
- Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFR gene
- P-glycoprotein immunohistochemistry score greater than 3 in tumor tissue after disease progression following regorafenib treatment
- Failure (progression or intolerance) of prior treatments including at least imatinib, sunitinib, and regorafenib
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- All toxic effects from prior treatments resolved to grade 0 or 1 according to NCI-CTCAE version 5.0
- At least one measurable lesion according to RECIST version 1.1
- Adequate bone marrow, liver, kidney, and other organ function as defined by specific blood count and chemistry thresholds
- Life expectancy greater than 12 weeks
- Washout period from previous tyrosine kinase inhibitors or chemotherapy of more than four times their half-life (1 week for imatinib and regorafenib, 2 weeks for sunitinib)
- Signed written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Women or men unwilling to use effective contraception during the study and for at least 3 months after last study drug administration
- History within 6 months prior to enrollment of serious cardiovascular events such as myocardial infarction, severe unstable angina, bypass surgery, severe heart failure (NYHA class III or IV), stroke, or severe arrhythmia requiring treatment
- Uncontrolled infection
- Acute or chronic liver diseases or impairments, except stable chronic hepatitis B
- Uncontrolled gastrointestinal toxicities above grade 2 by NCI CTCAE
- Acute or chronic medical or psychiatric conditions or lab abnormalities that would interfere with study participation
- History of life-threatening bleeding or grade 3 or 4 bleeding requiring medical intervention
- Current significant treatment with anticoagulants or thrombolytics (aspirin up to 325 mg/day allowed)
- Uncontrolled hypertension with blood pressure ≥140/90 mmHg not well controlled by medication
- Recent serious surgery, bone fracture, or non-healing wounds within 3 weeks prior to screening
- Significant cardiovascular or vascular diseases within 6 months prior to screening that may increase risk with VEGF inhibitor therapy
- History of serious kidney diseases or insufficiencies
- Known HIV infection
- Current clinically significant other primary malignancy requiring intervention
- Presence or suspicion of brain metastases
- Alcohol or substance abuse disorder
- Known severe allergy to rivoceranib or its components
- Concurrent treatment with strong CYP3A4, CYP2C9, or CYP2C19 inhibitors or inducers
- Active bacterial infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Seoul, South Korea, 138-736
Actively Recruiting
Research Team
R
Ryu Min-Hee, MD, PhD
CONTACT
K
kim Hyung-Don, MD, PhD
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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