A Phase I Study of Famitinib Malate in Patients With Solid Tumor
|ClinicalTrials.gov Identifier: NCT01762280|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: Famitinib Malate Capsule||Phase 1|
- 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 .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Famitinib Malate in Patients With Solid Tumor|
|Actual Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||July 2012|
Experimental: Famitinib Malate
Famitinib either at 4,8,13,20,27,36 mg, p.o. once daily
|Drug: Famitinib Malate Capsule|
- Maximum tolerated dose(MTD) [ Time Frame: 2 months ]
- Dose-limiting toxicity(DLT) [ Time Frame: 2 months ]
- Pharmacokinetics [ Time Frame: 2 months ]Famitinib pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2
- Objective response rate [ Time Frame: 2 months ]
- Number of volunteers with adverse events [ Time Frame: 2 months ]
- Pharmacodynamics [ Time Frame: 2 months ]The response of Famitinib on tumor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762280
|Cancer Institute and Hospital Chinese Academy of Medical Sciences|
|Principal Investigator:||Jinwan Wang, M.D||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|
|Principal Investigator:||Dafang Zhong, Ph.D||Chinese Academy of Science Shanghai Institution of Materia Medica|