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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences
Chinese Academy of Sciences
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01762280
First received: December 26, 2012
Last updated: January 4, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity(DLT) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2

  • Objective response rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Number of volunteers with adverse events [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01762280     History of Changes
Other Study ID Numbers: FMTN-I
Study First Received: December 26, 2012
Last Updated: January 4, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014