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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 Procedure: pharmacological study |
Phase I |
MedlinePlus related topics: | Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Liver Cancer Lymphoma |
Drug Information available for: | Dasatinib Salicylsalicylic acid Sodium salicylate |
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
Southwest Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | John Sarantopoulos, MD | Cancer Therapy and Research Center, Texas |
Investigator: | Chris H. Takimoto, MD, PhD, FACP | South Texas Accelerated Research Therapeutics |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000583976, SWOG-S0711 |
First Received: | January 30, 2008 |
Last Updated: | October 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00608361 |
Health Authority: | Unspecified |
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