A Study of Famitinib in Patients With Advanced Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Collaborators:
Beijing Cancer Hospital
Sun Yat-sen University
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01762293
First received: January 4, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention Phase
Colorectal Cancer
Colorectal Cancer Metastatic
Colorectal Cancer Recurrent
Drug: Famitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • Progression Free Survival(PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate(ORR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Disease Control Rate(DCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Overall Survival(OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 42-day cycle visit until disease progress ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • body vitals, laboratory parameters [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762293

Contacts
Contact: Haoyuan Jiang, Ph.D,M.D +86 21 68868768

Locations
China, Guangdong
Cancer center, Sun Yet-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Ruihua Xu    020-87343135      
Principal Investigator: Ruihua Xu, M.D         
China
Beijing Cancer Hospital, Peking University Recruiting
Beijing, China
Contact: Lin Shen, M.D    010-88196391      
Principal Investigator: Lin Shen, M.D         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Beijing Cancer Hospital
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
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01762293     History of Changes
Other Study ID Numbers: FMTN-IIb-CRC
Study First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
CRC
Famitinib
Phase II
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 31, 2014