A Phase I Study of Famitinib Malate in Patients With Solid Tumor
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 .
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose(MTD)
Jinwan Wang, M.D
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration