Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction

Title

Phase I Pharmacokinetic Study of Dasatinib (BMS-354825) (NSC-732517) in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction

Lead sponsor

National Cancer Institute (NCI)

Phase

Phase 1

Overall status

Completed

Start date

October 31, 2008

Completion date

August 31, 2014

Enrollment

80 (actual)

Sites

23

adult acute lymphoblastic leukemia in remission, adult b acute lymphoblastic leukemia, adult hepatocellular carcinoma, adult nasal type extranodal nk/t-cell lymphoma, adult solid neoplasm, adult t acute lymphoblastic leukemia, advanced adult hepatocellular carcinoma, anaplastic large cell lymphoma, angioimmunoblastic t-cell lymphoma, chronic lymphocytic leukemia, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue, hepatosplenic t-cell lymphoma, intraocular lymphoma, localized non-resectable adult liver carcinoma, localized resectable adult liver carcinoma, lymphomatous involvement of non-cutaneous extranodal site, mature t-cell and nk-cell non-hodgkin lymphoma, nodal marginal zone lymphoma, progressive hairy cell leukemia initial treatment, recurrent adult acute lymphoblastic leukemia, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult hodgkin lymphoma, recurrent adult immunoblastic lymphoma, recurrent adult liver carcinoma, recurrent adult lymphoblastic lymphoma, recurrent adult t-cell leukemia/lymphoma, recurrent cutaneous t-cell non-hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides and sezary syndrome, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, small intestinal lymphoma, splenic marginal zone lymphoma, stage ii small lymphocytic lymphoma, stage iii adult burkitt lymphoma, stage iii adult diffuse large cell lymphoma, stage iii adult diffuse mixed cell lymphoma, stage iii adult diffuse small cleaved cell lymphoma, stage iii adult hodgkin lymphoma, stage iii adult immunoblastic lymphoma, stage iii adult lymphoblastic lymphoma, stage iii adult t-cell leukemia/lymphoma, stage iii chronic lymphocytic leukemia, stage iii cutaneous t-cell non-hodgkin lymphoma, stage iii grade 1 follicular lymphoma, stage iii grade 2 follicular lymphoma, stage iii grade 3 follicular lymphoma, stage iii mantle cell lymphoma, stage iii marginal zone lymphoma, stage iii small lymphocytic lymphoma, stage iiia mycosis fungoides and sezary syndrome, stage iiib mycosis fungoides and sezary syndrome, stage iv adult burkitt lymphoma, stage iv adult diffuse large cell lymphoma, stage iv adult diffuse mixed cell lymphoma, stage iv adult diffuse small cleaved cell lymphoma, stage iv adult hodgkin lymphoma, stage iv adult immunoblastic lymphoma, stage iv adult lymphoblastic lymphoma, stage iv adult t-cell leukemia/lymphoma, stage iv chronic lymphocytic leukemia, stage iv cutaneous t-cell non-hodgkin lymphoma, stage iv grade 1 follicular lymphoma, stage iv grade 2 follicular lymphoma, stage iv grade 3 follicular lymphoma, stage iv mantle cell lymphoma, stage iv marginal zone lymphoma, stage iv small lymphocytic lymphoma, stage iva mycosis fungoides and sezary syndrome, stage ivb mycosis fungoides and sezary syndrome, t-cell large granular lymphocyte leukemia, testicular lymphoma, untreated adult acute lymphoblastic leukemia, untreated hairy cell leukemia, waldenstrom macroglobulinemia