GIST Oral Paclitaxel(Liporaxel)
ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorAsan Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Liporaxel
DrugLiporaxel 200mg/m2 twice daily orally on day 1, 8, and 15 every 4 weeks (1 cycle = 4 weeks)
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Oral Paclitaxel (Liporaxel)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
16 week disease control rate
according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame
16 weeksSecondary outcomes
1
Progression-free survival
time from the date of first administration of palliative first-line chemotherapy to the date of the first objectively documented tumor progression or death, whichever occurs first)
Time frame
until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months2
Overall survival
time from the date of first administration of palliative first-line chemotherapy to the date of death due to any cause
Time frame
through study completion, an average of 3 years3
Objective response rate
according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame
every 4 weeks for the initial two evaluation, then every 8 weeks4
Adverse event assessed by NCI-CTCAE Version 5.0
assessed by NCI-CTCAE Version 5.0
Time frame
until 28 days from the last administration of the investigational productSponsors and contacts
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Source ClinicalTrials.gov