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A Phase I Study of Famitinib Malate in Patients With Solid Tumor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Active, not recruiting
Chinese Academy of Medical Sciences
Chinese Academy of Sciences
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd. Identifier:
First received: December 26, 2012
Last updated: January 4, 2013
Last verified: January 2013
Famitinib is a novel oral multitargeted tyrosine kinase inhibitor with antitumor and antiangiogenic activities. This study is designed to evaluate the safety and tolerability of Famitinib in patients with solid tumor

Condition Intervention Phase
Advanced Solid Tumor
Drug: Famitinib Malate Capsule
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Famitinib Malate in Patients With Solid Tumor

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Maximum tolerated dose(MTD) [ Time Frame: 2 months ]
  • Dose-limiting toxicity(DLT) [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 months ]
    Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2

  • Objective response rate [ Time Frame: 2 months ]
  • Number of volunteers with adverse events [ Time Frame: 2 months ]
  • Pharmacodynamics [ Time Frame: 2 months ]
    The response of Famitinib on tumor.

Estimated Enrollment: 29
Study Start Date: June 2009
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Famitinib Malate
Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily
Drug: Famitinib Malate Capsule

Detailed Description:
  1. To evaluate the safety and tolerability of Famitinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
  2. To determine the pharmacokinetic profile of Famitinib and its metabolites .
  3. To assess preliminary antitumor activity .
  4. To determine preliminary dose and regimen for phase II study .

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Histological confirmed advanced or metastatic solid tumor,at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
  • no standard therapy protocol available according to patients'condition
  • both sex, age 18 to 65
  • ECOG 0-1
  • Life expectancy more than 3 months
  • ALT,AST,TB≤1.5(UNL),normal serum creatinine level, normal electrolyte or can be corrected by medication
  • Subjects receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery
  • Understand and agree to sign informed consent form.

Exclusion Criteria:

  • Peripheral neuropathy ≥ Grade 2(according to NCI-CTC 3.0)
  • Preexisting uncontrolled hypertension defined as more than 140/90 mmHg by using single agent therapy, >Grade 1 (NCI-CTCAE 3.0 ) myocardial ischemia, arrhythmia,cardiac function insufficiency
  • PT, APTT, TT, Fbg abnormal(PT>16s,APTT>43s,TT>21s,Fbg<2g/L), or have hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
  • Active peptic ulcer
  • Previously medication include sunitinib
  • More than 4 weeks since the last clinical trial
  • Pregnant or lactating women
  • Women of childbearing age do not take effective contraceptive measures
  • Allergies, or known allergy history to components of the drug
  Contacts and Locations
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Please refer to this study by its identifier: NCT01762280

Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Chinese Academy of Medical Sciences
Chinese Academy of Sciences
Principal Investigator: Jinwan Wang, M.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator: Dafang Zhong, Ph.D Chinese Academy of Science Shanghai Institution of Materia Medica
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT01762280     History of Changes
Other Study ID Numbers: FMTN-I
Study First Received: December 26, 2012
Last Updated: January 4, 2013

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Advanced Solid tumor
Phase I processed this record on May 25, 2017