A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
|ClinicalTrials.gov Identifier: NCT01416623|
Recruitment Status : Terminated
First Posted : August 15, 2011
Last Update Posted : December 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Cancer||Drug: henatinib||Phase 1|
- To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- To determine the pharmacokinetic profile of Henatinib and its metabolites .
- To assess preliminary antitumor activity .
- To determine preliminary regimen for phase II study .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Henatinib either at 12.5,25,37.5,50,62.5,75,87.5 or 100 mg, p.o. once daily
Henatinib Maleate Tablets
- The maximum-tolerated dose (MTD) regimen of henatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle. [ Time Frame: 4 weeks ]
- Number of participants with adverse events [ Time Frame: 8 weeks ]
- Henatinib pharmacokinetic parameters may include AUC, Cmax, Tmax, and t1/2. [ Time Frame: 4 weeks ]
- Objective response rate (ORR) [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416623
|Fudan University Shanghai Cancer Center|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||jin Li, Dr||Fudan University|