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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762280
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Chinese Academy of Medical Sciences
Chinese Academy of Sciences
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
  Purpose
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: None (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 .
  Eligibility

Information from the National Library of Medicine

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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

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): NCT01762280


Locations
China
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
Investigators
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.
ClinicalTrials.gov Identifier: NCT01762280     History of Changes
Other Study ID Numbers: FMTN-I
First Submitted: December 26, 2012
First Posted: January 7, 2013
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Famitinib
Advanced Solid tumor
Phase I