A Study of Famitinib in Patients With Advanced Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01762293 |
Recruitment Status :
Completed
First Posted : January 7, 2013
Last Update Posted : April 18, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Colorectal Cancer Metastatic Colorectal Cancer Recurrent | Drug: Famitinib Other: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | October 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Famitinib
Famitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
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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
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Other: placebo
p.o. qd |
- Progression Free Survival(PFS) [ Time Frame: 3 years ]
- 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 ]
- body vitals, laboratory parameters [ Time Frame: 3 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762293
China, Guangdong | |
Cancer center, Sun Yet-sen University | |
Guangzhou, Guangdong, China | |
China | |
Beijing Cancer Hospital, Peking University | |
Beijing, China |
Principal Investigator: | Shen Lin, M.D | Beijing Cancer Hospital, Peking University | |
Principal Investigator: | Ruihua Xu, M.D | Cancer Center, Sun Yet-sen University |
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01762293 |
Other Study ID Numbers: |
FMTN-IIb-CRC |
First Posted: | January 7, 2013 Key Record Dates |
Last Update Posted: | April 18, 2018 |
Last Verified: | January 2013 |
CRC Famitinib Phase II Colorectal Cancer |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |