NCT06326346 GIST Oral Paclitaxel(Liporaxel)
| NCT ID | NCT06326346 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Asan Medical Center |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2024-11-20 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age 20 years or older, at the time of acquisition of informed consent 2. Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene 3. Failed (progressed and/or intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib. 4. Adequate tissue obtained after treatment failure to imatinib, sunitinib, and regorafenib for P-glycoprotein immunohistochemistry (IHC) analysis, and showed P-glycoprotein expression of less than 6. (For patients with PDGFRα D842V mutation or other subtypes with poor response to tyrosine kinase inhibitors, tumor tissue obtained at any period can be used.) 5. Eastern Cooperative Oncology Group (ECOG) performance status 0\~2 6. Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0 7. At least one measurable lesion as defined by RECIST version 1.1. 8. Adequate bone marrow, hepatic, renal, and other organ functions * Neutrophil \>1,500/mm3 * Platelet \> 100,000/mm3 * Hemoglobin \>8.0 g/dL * Total bilirubin \< 1.5 x upper limit of normal (ULN) * AST/ALT \< 2.5 x ULN * Creatinine \<1.5 x ULN 9. Life expectancy \> 12 weeks 10. Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imatinib and regorafenib need 1 week and sunitinib need 2 weeks.) 11. Provision of a signed written informed consent Exclusion Criteria: 1. Women of child-bearing potential who are pregnant or breast feeding 2. Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration. 3. If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia. 4. Uncontrolled infection 5. Diabetes mellitus with clinically significant peripheral artery disease 6. Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible) 7. Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2 8. Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator 9. The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleeding event. (required transfusion or endoscopic or surgical intervention) 10. Patient who underwent major surgery or is under recovery from surgery within 28 days from the study treatment 11. Known diagnosis of HIV infection (HIV testing is not mandatory). 12. History of another primary malignancy that is currently clinically significant or currently requires active intervention. 13. Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging. 14. Alcohol or substance abuse disorder. 15. Known severe hypersensitivity to paclitaxel 16. Received paclitaxel-based treatment for GIST
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06326346 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06326346 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06326346 currently recruiting?
Yes, NCT06326346 is actively recruiting participants. Contact the research team at miniryu@amc.seoul.kr for enrollment information.
Where is the NCT06326346 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06326346 clinical trial?
NCT06326346 is sponsored by Asan Medical Center. The trial plans to enroll 28 participants.