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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00608361 |
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib in treating patients with metastatic or unresectable solid tumor or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dasatinib Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517; IND-73969) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction |
Estimated Enrollment: | 45 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to hepatic function as defined by the Child-Pugh classification system (control [i.e., total bilirubin normal, AST/ALT normal, and PT normal, and Child-Pugh classification score of 5] vs mild impairment [Child-Pugh class A] vs moderate impairment [Child-Pugh class B] vs severe impairment [Child-Pugh class C]).
Patients receive oral dasatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating dose of dasatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
Patients undergo blood sample collection on days 1 and 8 of course 1 for pharmacokinetic studies.
After completion of study treatment, patients are followed periodically for 28 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma
Patients with brain metastases requiring corticosteroids must be on a stable or decreasing dose of corticosteroids
No baseline pleural effusion or ascites
PATIENT CHARACTERISTICS:
Patients with biliary obstruction for which a shunt has been placed are eligible provided the liver function tests have stabilized
None of the following within the past 12 months:
No uncontrolled serious intercurrent medical illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic doses of anticoagulants
United States, Texas | |
Cancer Therapy and Research Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Clinical Trials Office - Cancer Therapy and Research Center 210-616-5798 | |
University Hospital - San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: John Sarantopoulos 210-358-4000 | |
University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229-3900 | |
Contact: John Sarantopoulos 210-567-4777 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | Recruiting |
San Antonio, Texas, United States, 78209 | |
Contact: John Sarantopoulos 210-617-5300 |
Study Chair: | John Sarantopoulos, MD | Cancer Therapy and Research Center, Texas |
Investigator: | Chris H. Takimoto, MD, PhD, FACP | South Texas Accelerated Research Therapeutics |
Study ID Numbers: | CDR0000583976, SWOG-S0711 |
Study First Received: | January 30, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00608361 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma Waldenstrom macroglobulinemia stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma |
stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
Sezary syndrome Liver Diseases Carcinoma, Hepatocellular Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Duodenal Neoplasms Lymphomatoid granulomatosis Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Dasatinib Lymphoma, Large-Cell, Anaplastic |
Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Digestive System Neoplasms Immunoproliferative Disorders Leukemia, B-cell, chronic Carcinoma Waldenstrom Macroglobulinemia B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Jejunal Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |