GIST Oral Paclitaxel(Liporaxel)

NCT06326346 | Not Yet Recruiting Phase 2

• 1 other identifier: AMC2401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• 16 week disease control rate

  according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  16 weeks

Secondary Outcomes (4)

• Progression-free survival

  until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

• Overall survival

  through study completion, an average of 3 years

• Objective response rate

  every 4 weeks for the initial two evaluation, then every 8 weeks

• Adverse event assessed by NCI-CTCAE Version 5.0

  until 28 days from the last administration of the investigational product

Study Arms (1)

Oral Paclitaxel (Liporaxel)

EXPERIMENTAL

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

Drug: Liporaxel

Interventions

Liporaxel DRUG

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

Oral Paclitaxel (Liporaxel)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpagu, 138-736, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Min-Hee Ryu, MD, PhD

CONTACT

82-2-3010-5936; miniryu@amc.seoul.kr

Hyung-Don Kim, MD, PhD

CONTACT

82-2-3010-0236; kimhdmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)