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

Gastrointestinal Stromal Tumors

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

Inclusion Criteria17

Age 20 years or older, at the time of acquisition of informed consent
Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
Failed (progressed and/or intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.
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.)
Eastern Cooperative Oncology Group (ECOG) performance status 0~2
Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
At least one measurable lesion as defined by RECIST version 1.1.
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
Life expectancy > 12 weeks
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.)
Provision of a signed written informed consent

Exclusion Criteria16

Women of child-bearing potential who are pregnant or breast feeding
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.
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.
Uncontrolled infection
Diabetes mellitus with clinically significant peripheral artery disease
Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)
Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2
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
The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleeding event. (required transfusion or endoscopic or surgical intervention)
Patient who underwent major surgery or is under recovery from surgery within 28 days from the study treatment
Known diagnosis of HIV infection (HIV testing is not mandatory).
History of another primary malignancy that is currently clinically significant or currently requires active intervention.
Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging.
Alcohol or substance abuse disorder.
Known severe hypersensitivity to paclitaxel
Received paclitaxel-based treatment for GIST