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

• 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 .

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