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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Chinese Academy of Medical Sciences; Chinese Academy of Sciences

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