Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT00459108|
Recruitment Status : Terminated (Halted early for futility.)
First Posted : April 11, 2007
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Drug: dasatinib||Phase 2|
I. Determine the progression-free survival (PFS) rate and response rate (complete and partial response) at 4 months in patients with unresectable advanced hepatocellular carcinoma treated with dasatinib.
I. Determine the median PFS and overall survival of patients treated with this drug.
II. Assess the toxicity and tolerability of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma|
|Study Start Date :||April 2007|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: Oral Dasatinib
Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Response Rate (Complete and Partial Response) [ Time Frame: 4 months ]Patients with confirmed partial or complete response using the RECIST criteria.
- Four Month Progression-free Survival (PFS) [ Time Frame: 4 months ]Progression-free survival calculated using the method of Kaplan-Meier.
- Median PFS [ Time Frame: Up to 4 years ]
- Overall Survival [ Time Frame: Up to 4 years ]
- Safety and Tolerability [ Time Frame: Up to 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459108
|United States, California|
|University of Southern California, Norris|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Heinz-Josef Lenz||City of Hope Medical Center|