A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|