A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor

• ClinicalTrials.gov Identifier: NCT02336724
• Recruitment Status: Unknown
• First Posted: January 13, 2015
• Last Update Posted: April 17, 2018
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: January 8, 2015
• First Posted Date: January 13, 2015
• Last Update Posted Date: April 17, 2018
• Study Start Date: March 2012
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 8, 2015): Disease Control Rate [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Famitinib in Patients With Gastrointestinal Stromal Tumor
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastrointestinal Stromal Tumor
• Intervention: Drug: Famitinib

Study Arms

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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 31, 2016): 88
• Original Estimated Enrollment (submitted: January 8, 2015): 82
• Estimated Study Completion Date: June 2019
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02336724
• Other Study ID Numbers: FMTN-II-GIST
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: January 2016