Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor

NCT05905887 | Recruiting Phase 2

• 1 other identifier: AMC2301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  at 12 weeks

Study Arms (1)

rivoceranib plus paclitaxel

EXPERIMENTAL

Drug: Rivoceranib Mesylate, Paclitaxel

Interventions

Rivoceranib Mesylate, Paclitaxel DRUG

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.

rivoceranib plus paclitaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

apatinib; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Ryu Min-Hee, MD, PhD

CONTACT

82-2-3010-5935; miniryu@amc.seoul.kr

kim Hyung-Don, MD, PhD

CONTACT

82-2-3010-0236; kimhdmd@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: September 6, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)