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

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.
 
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.

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Famitinib capsules Drug: Sunitinib Capsules Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 12, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Experimental: Famitinib Drug: Famitinib capsules
Oral KIT/PDGFRA kinase inhibitor

Active Comparator: Sunitinib Drug: Sunitinib Capsules
Oral receptor tyrosine kinase (RTK) inhibitor
Other Name: Sutent




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression-free survival (PFS) assessed by BIRC based on RECIST 1.1 criteria


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression-free survival (PFS) assessed by BIRC based on mRECIST criteria

  2. Progression-free survival (PFS) [ Time Frame: 30 months ]
    Progression-free survival (PFS) assessed by researchers based on RECIST 1.1 criteria

  3. 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)

  4. 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);

  5. 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)

  6. 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)

  7. 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)

  8. overall survival (OS) [ Time Frame: 30 months ]
    Based on the RECIST v1.1 criteria, BIRC and the researchers' evaluation of: overall survival (OS)

  9. Adverse Events and Serious Adverse Events [ Time Frame: 30 months ]
    Adverse Events and Serious Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04409223


Contacts
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Contact: Quanren Wang, MD (+86) 021-50118402 wangquanren@hrglobe.cn

Locations
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China
307 Hospital of PLA Recruiting
Beijing, China
Contact: jianming xu, PHD       jmxu2003@yahoo.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Jianming Xu, MD The fifth medical center of PLA general hospital
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04409223    
Other Study ID Numbers: SHR-1020-Ⅲ-303
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action