A Study of Famitinib in Patients With Advanced Colorectal Cancer

• ClinicalTrials.gov Identifier: NCT01762293
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: April 18, 2018
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Peking University Cancer Hospital & Institute; Sun Yat-sen University
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: January 4, 2013
• First Posted Date: January 7, 2013
• Last Update Posted Date: April 18, 2018
• Study Start Date: April 2012
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 4, 2013): Progression Free Survival(PFS) [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 4, 2013)

• Objective response rate(ORR) [ Time Frame: 12 weeks ]
• Disease Control Rate(DCR) [ Time Frame: 12 weeks ]
• Overall Survival(OS) [ Time Frame: 3 years ]
• Quality of Life [ Time Frame: 42-day cycle visit until disease progress ]
• Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: January 4, 2013): body vitals, laboratory parameters [ Time Frame: 3 years ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study of Famitinib in Patients With Advanced Colorectal Cancer
• Official Title: A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer

Brief Summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the toxicity is manageable.

The purpose of this study is to determine whether Famitinib can improve progression free survival compared with placebo in patients with advanced colorectal cancer who failed in previous at least two lines of chemotherapy.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Colorectal Cancer
• Colorectal Cancer Metastatic
• Colorectal Cancer Recurrent

Intervention

• Drug: Famitinib
  Famitinib 25 mg p.o. qd
• Other: placebo
  p.o. qd

Study Arms

• Experimental: Famitinib
  Famitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
  Intervention: Drug: Famitinib
• Placebo Comparator: Placebo
  Placebo qd p.o., and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
  Intervention: Other: placebo

• Publications *: Xu RH, Shen L, Wang KM, Wu G, Shi CM, Ding KF, Lin LZ, Wang JW, Xiong JP, Wu CP, Li J, Liu YP, Wang D, Ba Y, Feng JP, Bai YX, Bi JW, Ma LW, Lei J, Yang Q, Yu H. Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Chin J Cancer. 2017 Dec 22;36(1):97. doi: 10.1186/s40880-017-0263-y.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2018): 154
• Original Estimated Enrollment (submitted: January 4, 2013): 150
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologic confirmed recurrent and/or metastatic CRC and previously received at least two lines of standard therapy failure(must include 5-Fu,irinotecan and oxaliplatin)
• At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
• age ≥ 18 and ≤ 70
• ECOG 0-1
• Life expectancy of more than 3 months
• More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors
• Signed and dated informed consent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

• Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit(e.g sorafenib,sunitinib,regorafenib)
• Any factors that influence the usage of oral administration
• Having obvious gastrointestinal hemorrhagic tendency
• Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
• Organ tumor overloading
• Inadequate hepatic, renal, heart, and hematologic functions (hemoglobin ≤ 90g/L, platelets ≤ 100×10^9/L, neutrophils ≤ 1.5×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), and serum transaminase ≥ 1.5×ULN (If liver metastases, serum transaminase≥ 2.5×ULN), creatinine clearance rate ≤ 60ml/min, cholesterol ≥ 1.5×ULN and triglyceride≥ 2.5 x ULN, LVEF: < 50%
• Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency
• urinary protein≥ ++ or 24-hour urinary protein ≥ 1.0 g
• Long-term untreated wounds or fractures
• Blood coagulation abnormal, having hemorrhagic tendency
• Within 1 year 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.
• Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed
• Female: 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 article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: 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 article.
• Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
• Abuse of psychiatric drugs or dysphrenia
• Less than 4 weeks from the last clinical trial
• Ascites need treatment
• Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 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: NCT01762293
• Other Study ID Numbers: FMTN-IIb-CRC
• Has Data Monitoring Committee: Yes
• 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

• Peking University Cancer Hospital & Institute
• Sun Yat-sen University

Investigators

• Principal Investigator: Shen Lin, M.D; Beijing Cancer Hospital, Peking University
• Principal Investigator: Ruihua Xu, M.D; Cancer Center, Sun Yet-sen University

• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: January 2013