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New treatment option for Gastrointestinal Stromal Tumors
Official title Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
ClinicalTrials.gov ID: NCT05905887
What this study is testing
What is Rivoceranib Mesylate, Paclitaxel?
Rivoceranib Mesylate, Paclitaxel is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gastrointestinal stromal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join 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
- 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
You likely can't join 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...
- If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina...
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.