Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
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 the efficacy and safety of rivoceranib and paclitaxel combination therapy in patients with P-glycoprotein overexpressing GIST who failed standard treatment with imatinib, sunitinib, and regorafenib.
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
P-glycoprotin IHC score > 3 (Tumor tissue with disease progression after regorafenib treatment)
Failed (progressed and/or intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.
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
Rivoceranib Mesylate, Paclitaxel
DrugPaclitaxel will be administered at 80mg/m2/day every four weeks at Day 1, Day 8 and Day 15 per cycle. One cycle consists of 4 weeks (28 days). Rivoceranib 400 mg orally once a day.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: rivoceranib plus paclitaxelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease control rate
Time frame
at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov