Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
---|---|
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 Other: 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: | October 2008 |
Estimated Primary Completion Date: | August 2009 (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: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00608361 History of Changes |
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 |
Liver Diseases Carcinoma, Hepatocellular Lymphoma, Mantle-Cell Mantle Cell Lymphoma Protein Kinase Inhibitors Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Dasatinib Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Digestive System Neoplasms |
Immunoproliferative Disorders Carcinoma Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Gastrointestinal Diseases Lymphoma, Follicular Central Nervous System Lymphoma, Primary Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma |
Liver Diseases Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Ileal Diseases Protein Kinase Inhibitors Duodenal Neoplasms Liver Neoplasms Neoplasms by Site Ileal Neoplasms Jejunal Diseases Dasatinib Lymphoma Duodenal Diseases Jejunal Neoplasms |
Neoplasms by Histologic Type Digestive System Neoplasms Immunoproliferative Disorders Immune System Diseases Enzyme Inhibitors Intestinal Diseases Pharmacologic Actions Intestinal Neoplasms Lymphatic Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |