The classic website will no longer be available as of June 25, 2024. Please use the modernized
Working… Menu

Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05905887
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : February 28, 2024
Information provided by (Responsible Party):
Min-Hee Ryu, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Rivoceranib Mesylate, Paclitaxel Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Paclitaxel Plus Rivoceranib in Patients With GIST With a High P-glycoprotein Expression After Failure With at Least Imatinib, Sunitinib and Regorafenib
Actual Study Start Date : September 6, 2023
Estimated Primary Completion Date : August 31, 2026
Estimated Study Completion Date : December 31, 2026

Arm Intervention/treatment
Experimental: rivoceranib plus paclitaxel Drug: Rivoceranib Mesylate, Paclitaxel

Paclitaxel 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.

Primary Outcome Measures :
  1. Disease control rate [ Time Frame: at 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05905887

Layout table for location contacts
Contact: Ryu Min-Hee, MD, PhD 82-2-3010-5935
Contact: kim Hyung-Don, MD, PhD 82-2-3010-0236

Layout table for location information
Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Min-Hee Kang, MD, PhD    +82-2-3010-5935   
Contact: Hyung-Don Kim, MD, PhD    +82-2-3010-0236   
Sponsors and Collaborators
Asan Medical Center
Layout table for additonal information
Responsible Party: Min-Hee Ryu, Professor, Asan Medical Center Identifier: NCT05905887    
Other Study ID Numbers: AMC2301
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors