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A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor

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ClinicalTrials.gov Identifier: NCT02336724
Recruitment Status : Unknown
Verified January 2016 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE January 13, 2015
Last Update Posted Date April 17, 2018
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
Disease Control Rate [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2015)
  • Objective Response Rate [ Time Frame: 12 weeks ]
  • Progression free survival [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 96 months ]
  • Incidence of adverse events [ Time Frame: 24 months ]
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 A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
Official Title  ICMJE A Single Arm, Open Label, Multicenter, Phase II Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
Brief Summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.

The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with advanced or metastatic gastrointestinal stromal tumor who failed from imatinib therapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumor
Intervention  ICMJE Drug: Famitinib
Study Arms  ICMJE Experimental: Famitinib
25 mg qd p.o.,28 days as one cycle,treatment discontinued when disease progression determined or intolerable toxicity or patients withdrawal of consent
Intervention: Drug: Famitinib
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: January 31, 2016)
88
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2015)
82
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unresectable advanced or metastatic, histologically-confirmed, gastrointestinal stromal tumor.Patients has been failed from last imatinib treatment due to disease progression or unacceptable toxicity and unable to use sunitinib.
  • At least 2 weeks since the last imatinib administration
  • Must have at least one measurable disease by RECIST1.1 criteria(tumour lesions ≥10mm in longest diameter, malignant lymph nodes ≥15mm in short axis, scanning layer ≤ 5 mm).
  • ECOG Performance status 0-1
  • Participants have adequate organ and marrow function as defined below:

neutrophils ≥ 1.5×10^9/L, platelets≥ 80×10^9/L, hemoglobin≥ 90g/L (no blood transfusion within 14 days), serum transaminase(ALT and AST ) ≤ 2.5×ULN (If liver metastases are present, serum transaminase≤5×ULN), total bilirubin ≤ 1.25×ULN, cholesterol ≤ 7.75mmol/L and triglyceride≤1 x ULN, creatinine ≤1x ULN,creatinine clearance rate > 50ml/min Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g normal serum calcium, potassium,magnesium, phosphorus INR≤1.5 and APTT≤1.5 ULN LVEF: ≥ 50%

  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit
  • The toxicity from previous imatinib or other treatment has not been recovered ≤ grade 1 according to CTCAE 3.0
  • Have surgery or radiotherapy within 4 weeks or have temporary radiotherapy for palliative treatment within 2 weeks
  • A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
  • Other cancer diagnosed within past 5 years or currently suffering , but other than cure basal cell carcinoma and cervical carcinoma in situ
  • Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
  • Uncontrollable thyroid dysfunction, even using medical therapy
  • Preexisting arrhythmia (including QT interval ≥ 450ms for male and 470ms for female) and ≥ grade I heart failure
  • Patients with uncontrollable hypertension after using single agent therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg).
  • Known acute or chronic active hepatitis
  • Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
  • Less than 4 weeks from the last clinical trial
  • Child bearing or pregnancy female. Potential child bearing female must have a negative urine or serum pregnancy test result before initiating.
  • All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test drug.
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
  • Mental disorders history, or Psychotropic drug abuse history
  • Abuse of Psychiatric drugs or dysphrenia
  • Other reasons from investigators' judgement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02336724
Other Study ID Numbers  ICMJE FMTN-II-GIST
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date January 2016

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