Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma|
- Response Rate (Complete and Partial Response) [ Time Frame: 4 months ] [ Designated as safety issue: No ]Patients with confirmed partial or complete response using the RECIST criteria.
- Four Month Progression-free Survival (PFS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]Progression-free survival calculated using the method of Kaplan-Meier.
- Median PFS [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Safety and Tolerability [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|