Actively Recruiting
GIST Oral Paclitaxel(Liporaxel)
Led by Asan Medical Center · Updated on 2026-04-07
28
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.
CONDITIONS
Official Title
GIST Oral Paclitaxel(Liporaxel)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at the time of consent
- Histologically confirmed metastatic or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
- Disease progression or intolerance after prior treatment with imatinib, sunitinib, and regorafenib
- Tissue available showing P-glycoprotein expression less than 6 by immunohistochemistry after failure of prior treatments (or any period for certain PDGFRα mutations)
- ECOG performance status between 0 and 2
- All toxic effects from prior treatments resolved to grade 0 or 1 per NCI-CTCAE version 5.0
- At least one measurable lesion per RECIST version 1.1
- Adequate bone marrow, liver, kidney, and other organ function (specific blood count and chemistry criteria)
- Life expectancy longer than 12 weeks
- Washout period of previous tyrosine kinase inhibitors or chemotherapy for more than four times their half-life
- 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 3 months after last dose
- History within 6 months of myocardial infarction, severe angina, coronary or peripheral bypass, severe heart failure (NYHA class III or IV), stroke or transient ischemic attack, or severe arrhythmia requiring treatment
- Uncontrolled infection
- Diabetes with significant peripheral artery disease
- Acute or chronic liver disease or impairment (except stable chronic hepatitis B)
- Uncontrolled gastrointestinal toxicities above grade 2
- Acute or chronic medical or psychiatric conditions or lab abnormalities making study participation difficult
- Life-threatening or severe bleeding episodes requiring transfusion or intervention
- Major surgery within 28 days before study treatment
- Known HIV infection
- History of another primary malignancy currently significant or requiring active treatment
- Suspected or confirmed brain metastases
- Alcohol or substance abuse disorder
- Known severe hypersensitivity to paclitaxel
- Previous paclitaxel-based treatment for GIST
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, Songpagu, South Korea, 138-736
Actively Recruiting
Research Team
M
Min-Hee Ryu, MD, PhD
CONTACT
H
Hyung-Don Kim, 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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