Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor

Launched by ASAN MEDICAL CENTER · Jun 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, rivoceranib and paclitaxel, to see how well they work and how safe they are for patients with a type of cancer called gastrointestinal stromal tumors (GIST). This trial specifically focuses on patients whose tumors have certain characteristics and who have not responded to standard treatments like imatinib, sunitinib, and regorafenib. The goal is to find out if this new treatment can help those who have run out of other options.

To be eligible for this trial, participants need to be at least 20 years old and have a confirmed diagnosis of advanced GIST. They must also have specific markers in their tumor and have experienced progression of their disease after previous treatments. Participants should have a measurable tumor and good overall health, meaning they can carry out daily activities. During the trial, participants will receive the combination treatment and will be monitored for any side effects, as well as how well the treatment works. It's important for potential participants to understand the eligibility criteria and discuss any concerns with their healthcare provider before considering joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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 ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)
• • Provision of a signed written informed consent
• Exclusion Criteria:
• • 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
• • 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 bleedig event. (required transfusion or endoscopic or surgical intervention)
• • Currently clinically significant (within 7 days prior to screening) treatment of anticoagulants or other thrombolytic agents. A maximum dose of 325 mg/day of aspirin is allowed
• • History of uncontrolled hypertension (blood pressure ≥140/90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.
• • History of clinically serious opearation, bone fracture or non-healing wounds within the last 3 weeks prior to screening
• • History of other significant cardiovascular diseases or vascular diseases, within the last 6 months prior to screening (e.g., hypertensive crisis, and hypertensive encephalopathy or transient ischemic attack or significant peripheral vascular diseases\] that, in the investigator's opinion, may pose a risk to the patient on VEGFR inhibitor therapy.
• • History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies
• • 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 hypersensitivity to rivoceranib or any component of its formulation or history of severe hypersensitivity to including Cremophor R EL(polyoxyethylated castor oil) drug
• • Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
• • Active bacterial infections