GIST Oral Paclitaxel(Liporaxel)

Launched by ASAN MEDICAL CENTER · Mar 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Liporaxel for patients with gastrointestinal stromal tumors (GIST) who have not responded well to standard treatments like imatinib, sunitinib, or regorafenib. The study aims to find out if Liporaxel is safe and effective for these patients, particularly those with low levels of a specific protein called P-glycoprotein. The trial is not yet recruiting participants, but it will welcome adults aged 20 and older who have advanced GIST and have previously failed at least two treatments.

To be eligible, participants need to have stable organ function and a life expectancy of more than 12 weeks. They should also have measurable tumors to assess how well the treatment works. However, there are some criteria that might exclude potential participants, such as being pregnant or having certain serious health conditions. If someone qualifies and decides to participate, they can expect to receive Liporaxel and be monitored closely for safety and effectiveness throughout the trial. This study represents an important step in exploring new options for patients who have exhausted their current treatment options.

Gender

ALL

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