RecruitingPhase 2NCT06326346

GIST Oral Paclitaxel(Liporaxel)

A Phase II Study of Oral Paclitaxel (Liporaxel) in GIST Patients With a Low P-glycoprotein Expression After Failure With Imatinib, Sunitinib and Regorafenib


Sponsor

Asan Medical Center

Enrollment

28 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests Liporaxel — an oral (pill) form of paclitaxel chemotherapy — as a treatment for patients with advanced gastrointestinal stromal tumors (GIST) that have stopped responding to three prior standard targeted therapies (imatinib, sunitinib, and regorafenib). GIST is a type of tumor in the digestive tract, and most patients eventually develop resistance to the standard drugs, leaving few options. Eligible participants are adults aged 20 or older with histologically confirmed advanced or metastatic GIST, who have failed all three prior treatments and whose tumors show low expression of a resistance protein called P-glycoprotein; those with severe heart disease, active infections, or prior paclitaxel treatment for GIST are excluded. Participation involves taking Liporaxel orally according to a set schedule, with regular imaging, blood tests, and clinic visits to monitor tumor response and side effects. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLiporaxel

Liporaxel 200mg/m2 twice daily orally on day 1, 8, and 15 every 4 weeks (1 cycle = 4 weeks)


Locations(1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpagu, South Korea

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NCT06326346


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