A Study of Famitinib in Patients With Advanced Colorectal Cancer

Hengrui Medicine

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer Recurrent

Colorectal Cancer Metastatic

Colorectal Cancer

Treatments

Drug: Famitinib

Other: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01762293

FMTN-IIb-CRC

Details and patient eligibility

About

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.

Enrollment

154 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.