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Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib

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ClinicalTrials.gov Identifier: NCT04409223
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 27, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date December 1, 2020
Actual Study Start Date  ICMJE September 12, 2020
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
Progression-free survival (PFS) [ Time Frame: 30 months ]
Progression-free survival (PFS) assessed by BIRC based on RECIST 1.1 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression-free survival (PFS) assessed by BIRC based on mRECIST criteria
  • Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression-free survival (PFS) assessed by researchers based on RECIST 1.1 criteria
  • time to disease progression (TTP) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: time to disease progression (TTP)
  • Time to treatment failure (TTF) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Time to treatment failure (TTF);
  • Objective response rate (ORR) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Objective response rate (ORR)
  • Duration of Response (DOR) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Duration of Response (DOR)
  • Disease control rates (DCR) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: Disease control rates (DCR)
  • overall survival (OS) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: overall survival (OS)
  • Adverse Events and Serious Adverse Events [ Time Frame: 30 months ]
    Adverse Events and Serious Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE
  • Drug: Famitinib capsules
    Oral KIT/PDGFRA kinase inhibitor
  • Drug: Sunitinib Capsules
    Oral receptor tyrosine kinase (RTK) inhibitor
    Other Name: Sutent
Study Arms  ICMJE
  • Experimental: Famitinib
    Intervention: Drug: Famitinib capsules
  • Active Comparator: Sunitinib
    Intervention: Drug: Sunitinib Capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2020)
304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The patients were enrolled voluntarily and signed informed consent, with good compliance and follow-up
  2. Age ≥18 years (on the date of signing informed consent), for both men and women
  3. Histologically confirmed metastatic or untreatable gastrointestinal stromal tumors have at least one measurable lesion that meets the criteria of RECIST v1.1. Lesions that have undergone radiotherapy must be confirmed by imaging to show progression after radiotherapy
  4. Previous treatment with imatinib and eventual treatment failure (disease progression or toxicity intolerance during treatment)
  5. 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.

  6. Eastern Cooperative Oncology Group performance status of 1 or lower
  7. Expected survival ≥12 weeks
  8. 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):

    Neutrophil absolute count ≥1.5×109/L; Platelet ≥ 100×109/L; Hemoglobin ≥ 90 g/L; Bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN serum creatinine≤1.5×ULN; Results of urinary protein <2+; If urinary protein is ≥2+, 24-hour quantitative determination of urinary protein should be conducted, and no more than 1g/24 hour is qualified. Serum calcium, potassium, magnesium and phosphorus are within the normal range or have been corrected to the normal range before randomization. International standardized ratio INR≤ 1.5 and activated partial thromboplastin time APTT≤1.5×ULN; QTc≤ 450 ms (male), 470 ms (female); Left ventricular ejection fraction LVEF≥50%.

  9. Use of a medically approved contraceptive method (e.g., intrauterine contraceptive device, contraceptive pill or condom) during the study period and within 90 days after the end of the study period for female patients of non-surgical sterilization or childbearing age; The serum HCG of female patients of childbearing age without surgical sterilization must be negative within 72 hours before randomization, and must be non-lactating to be enrolled; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the study period and within 90 days after the end of the study period.

Exclusion Criteria:

  1. Previously received molecular targeted therapy for gastrointestinal stromal tumor except imatinib
  2. The toxicity of previous imatinib or other treatments has not recovered or reached NCI CTC AE 5.0≤ 1
  3. 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.
  4. 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
  5. Gastrointestinal stromal tumor with central nervous system metastasis
  6. Inability to swallow, chronic diarrhea, intestinal obstruction, or factors that affect drug use and absorption
  7. Bleeding≥ grade 2 occurred in the first 4 weeks of randomization (NCI, CTC, AE 5.0)
  8. 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
  9. 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
  10. 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;
  11. Drug uncontrollable thyroid dysfunction
  12. Known acute or chronic active hepatitis, HBV virus titer > 500 IU, HCV RNA detection > ULN
  13. History of immunodeficiency, including HIV positive, acquired or congenital immunodeficiency disorder, or a history of organ transplantation
  14. Major surgery or radiotherapy within the first 4 weeks of randomization, or temporary palliative radiotherapy for pain relief within the first 1 week of randomization; Molecular-targeted therapy (including oral targeted drugs in other clinical trials) is less than 5 drug half-lives away form randomization date
  15. Participated in clinical trials of other drugs in the first 4 weeks of randomization
  16. Digestive tract perforation occurred 3 months before randomization
  17. In the judgment of the investigator, a concomitant illness (severe diabetes, a clear history of neurological or mental disorders, e.g., epilepsy or dementia) that seriously endangers the patient's safety or prevents the patient from completing the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Quanren Wang, MD (+86) 021-50118402 wangquanren@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409223
Other Study ID Numbers  ICMJE SHR-1020-Ⅲ-303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianming Xu, MD Beijing 302 Hospital
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP