Trials / Terminated
TerminatedNCT00459108
Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well dasatinib works in treating patients with advanced liver cancer that cannot be removed by surgery. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Conditions
- Adult Primary Hepatocellular Carcinoma
- Advanced Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dasatinib | Given orally |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2007-04-11
- Last updated
- 2018-04-19
- Results posted
- 2015-03-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00459108. Inclusion in this directory is not an endorsement.