Dasatinib in Treating Patients With Advanced Liver Cancer That Cannot Be Removed by Surgery
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|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 : April 19, 2018
|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|
|Actual Primary Completion Date :||April 2011|
|Actual 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 ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR
- Four Month Progression-free Survival (PFS) [ Time Frame: 4 months ]Progression-free survival calculated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Median Progression-free Survival [ Time Frame: Until disease progression or death, up to 4 years ]Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival [ Time Frame: Up to 4 years ]Estimated using the product-limit method of Kaplan and Meier.
- Safety and Tolerability [ Time Frame: Up to 4 years ]Summarize observed grade 3 and higher toxicities related to dasatanib. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 were used for reporting.
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): 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|