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

Study Overview
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Brief Summary
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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

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

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: Famitinib Malate Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famitinib Malate<br>Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily | Drug: Famitinib Malate Capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose(MTD) |  | 2 months | 
| Dose-limiting toxicity(DLT) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2 | 2 months | 
| Objective response rate |  | 2 months | 
| Number of volunteers with adverse events |  | 2 months | 
| Pharmacodynamics | The response of Famitinib on tumor. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Famitinib, Advanced Solid tumor, Phase I