NCT01762293

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 18, 2018

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

January 4, 2013

Last Update Submit

April 16, 2018

Conditions

Colorectal CancerColorectal Cancer MetastaticColorectal Cancer Recurrent

Keywords

CRCFamitinibPhase IIColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival(PFS)

    3 years

Secondary Outcomes (5)

  • Objective response rate(ORR)

    12 weeks

  • Disease Control Rate(DCR)

    12 weeks

  • Overall Survival(OS)

    3 years

  • Quality of Life

    42-day cycle visit until disease progress

  • Number of Participants with Adverse Events as a Measure of Safety

    3 years

Other Outcomes (1)

  • body vitals, laboratory parameters

    3 years

Study Arms (2)

Famitinib

EXPERIMENTAL

Famitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Famitinib

Placebo

PLACEBO COMPARATOR

Placebo qd p.o., and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent

Other: placebo

Interventions

FamitinibDRUG

Famitinib 25 mg p.o. qd

Famitinib
placeboOTHER

p.o. qd

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer center, Sun Yet-sen University

Guangzhou, Guangdong, China

Location

Beijing Cancer Hospital, Peking University

Beijing, China

Location

Related Publications (1)

  • Xu RH, Shen L, Wang KM, Wu G, Shi CM, Ding KF, Lin LZ, Wang JW, Xiong JP, Wu CP, Li J, Liu YP, Wang D, Ba Y, Feng JP, Bai YX, Bi JW, Ma LW, Lei J, Yang Q, Yu H. Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Chin J Cancer. 2017 Dec 22;36(1):97. doi: 10.1186/s40880-017-0263-y.

    PMID: 29273089DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

famitinib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Shen Lin, M.D

    Beijing Cancer Hospital, Peking University

    PRINCIPAL INVESTIGATOR

  • Ruihua Xu, M.D

    Cancer Center, Sun Yet-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 7, 2013

Study Start

April 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

April 18, 2018

Record last verified: 2013-01

Locations

CN(2)