A Phase III, Open Label, Randomised，Controlled, Multi-centre Study to Assess the Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country185 target enrollmentSeptember 12, 2020

ConditionsGastrointestinal Stromal Tumors

InterventionsFamitinib capsules Sunitinib Capsules

DrugsFamitinib capsules Sunitinib Capsules

Overview

Phase: Phase 3
Intervention: Famitinib capsules
Conditions: Gastrointestinal Stromal Tumors
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 185
Locations: 1
Primary Endpoint: Progression-free survival (PFS)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the efficacy and safety of famitinib in the treatment of advanced gastrointestinal stromal tumour patients after failure of imatinib compared to sunitinib.

Registry

clinicaltrials.gov

Start Date

September 12, 2020

End Date

March 25, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patients were enrolled voluntarily and signed informed consent, with good compliance and follow-up
•Age ≥18 years (on the date of signing informed consent), for both men and women
•Histologically confirmed metastatic or untreatable gastrointestinal stromal tumors have at least one measurable lesion that meets the criteria of RECIST v1.
•Lesions that have undergone radiotherapy must be confirmed by imaging to show progression after radiotherapy
•Previous treatment with imatinib and eventual treatment failure (disease progression or toxicity intolerance during treatment)
•The subjects were able to provide 10 ml blood samples and fresh or archived tumor tissue, or to receive biopsy at baseline for biomarker analysis.
•Note: if there is no archived tumor tissue sample, those at high risk of receiving biopsy after assessment by the researcher, who can provide the previous c-kit /PDGFRA test report, may also be selected for inclusion.
•Eastern Cooperative Oncology Group performance status of 1 or lower
•Expected survival ≥12 weeks
•Vital organs and body functions meet the following requirements (no blood products or cell agents are allowed to be used within 14 days before the first use):

Exclusion Criteria

•Previously received molecular targeted therapy for gastrointestinal stromal tumor except imatinib
•The toxicity of previous imatinib or other treatments has not recovered or reached NCI CTC AE 5.0≤ 1
•For patients with clinical symptoms of ascites or pleural effusion, those requiring puncture drainage or those who had received thoracic or ascites drainage within 1 month before signing informed consent were excluded, those with only small amount of ascites or pleural effusion on imaging but no clinical symptoms are qualified.
•A second primary malignancy occurred within the last 5 years, except for adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix
•Gastrointestinal stromal tumor with central nervous system metastasis
•Inability to swallow, chronic diarrhea, intestinal obstruction, or factors that affect drug use and absorption
•Bleeding≥ grade 2 occurred in the first 4 weeks of randomization (NCI, CTC, AE 5.0)
•Symptoms occurred within 12 months before randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or an arteriovenous embolism event (e.g., deep venous embolism of lower extremities, pulmonary embolism) within 6 months
•There are clinical symptoms or diseases of the heart that are not well controlled, such as (1) heart failure above NYHA grade 2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
•Have hypertension, and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥ 140mmhg or diastolic blood pressure ≥ 90mmhg, if the blood pressure was abnormal during the screening period, 2 consistent measurements must be done with an interval of more than 24h after medical correction); Previous hypertensive crisis or hypertensive encephalopathy;