Overview

This trial is active, not recruiting.

Condition advanced solid tumor
Treatment famitinib malate capsule
Phase phase 1
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Collaborator Chinese Academy of Medical Sciences
Start date June 2009
End date January 2013
Trial size 29 participants
Trial identifier NCT01762280, FMTN-I

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily
famitinib malate capsule

Primary Outcomes

Measure
Maximum tolerated dose(MTD)
time frame: 2 months
Dose-limiting toxicity(DLT)
time frame: 2 months

Secondary Outcomes

Measure
Pharmacokinetics
time frame: 2 months
Objective response rate
time frame: 2 months
Number of volunteers with adverse events
time frame: 2 months
Pharmacodynamics
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase I Study of Famitinib Malate in Patients With Solid Tumor
Principal investigator Jinwan Wang, M.D
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 .
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Jiangsu HengRui Medicine Co., Ltd..