A Study of Famitinib in Patients With Advanced Colorectal Cancer

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jan 4, 2013

Keywords

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Gender

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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.