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A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer, Colorectal Cancer Metastatic, Colorectal Cancer Recurrent

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Trial Information

A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer


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.

Type of Study:

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

Outcome Measure:

Progression Free Survival(PFS)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Shen Lin, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital, Peking University

Authority:

China: Food and Drug Administration

Study ID:

FMTN-IIb-CRC

NCT ID:

NCT01762293

Start Date:

April 2012

Completion Date:

January 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer Metastatic
  • Colorectal Cancer Recurrent
  • CRC
  • Famitinib
  • Phase II
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

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