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History of Changes for Study: NCT01762293
A Study of Famitinib in Patients With Advanced Colorectal Cancer
Latest version (submitted April 16, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 4, 2013 None (earliest Version on record)
2 April 16, 2018 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Design
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Study NCT01762293
Submitted Date:  January 4, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: FMTN-IIb-CRC
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2013
Overall Status: Recruiting
Study Start: April 2012
Primary Completion: October 2013 [Anticipated]
Study Completion: January 2014 [Anticipated]
First Submitted: January 4, 2013
First Submitted that
Met QC Criteria:
January 4, 2013
First Posted: January 7, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 4, 2013
Last Update Posted: January 7, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible Party: Sponsor
Collaborators: Peking University Cancer Hospital & Institute
Sun Yat-sen University
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Colorectal Cancer
Colorectal Cancer Metastatic
Colorectal Cancer Recurrent
Keywords: CRC
Famitinib
Phase II
Colorectal Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Famitinib
Famitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Famitinib
Famitinib 25 mg p.o. qd
Placebo Comparator: Placebo
Placebo qd p.o., and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression Free Survival(PFS)
[ Time Frame: 3 years ]

Secondary Outcome Measures:
1. Objective response rate(ORR)
[ Time Frame: 12 weeks ]

2. Disease Control Rate(DCR)
[ Time Frame: 12 weeks ]

3. Overall Survival(OS)
[ Time Frame: 3 years ]

4. Quality of Life
[ Time Frame: 42-day cycle visit until disease progress ]

5. Number of Participants with Adverse Events as a Measure of Safety
[ Time Frame: 3 years ]

Other Outcome Measures:
1. body vitals, laboratory parameters
[ Time Frame: 3 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Haoyuan Jiang, Ph.D,M.D
Telephone: +86 21 68868768
Study Officials: Shen Lin, M.D
Principal Investigator
Beijing Cancer Hospital, Peking University
Ruihua Xu, M.D
Principal Investigator
Cancer Center, Sun Yet-sen University
Locations: China
Beijing Cancer Hospital, Peking University
[Recruiting]
Beijing, China
Contact:Contact: Lin Shen, M.D 010-88196391
Contact:Principal Investigator: Lin Shen, M.D
China, Guangdong
Cancer center, Sun Yet-sen University
[Recruiting]
Guangzhou, Guangdong, China
Contact:Contact: Ruihua Xu 020-87343135
Contact:Principal Investigator: Ruihua Xu, M.D
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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