Spots Global Cancer Trial Database for Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

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Trial Identification

Brief Title: Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

Official Title: Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)

Study ID: NCT00047502

Conditions

Chronic Myelogenous Leukemia

Interventions

Lonafarnib (SCH66336)

Imatinib Mesylate (Gleevec)

Study Description

Brief Summary: The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.

Detailed Description: Existing pre-clinical and clinical data suggest that SCH66336, a farnesyl transferase inhibitor,exhibits significant activity against CML cells, and in fact may have synergistic activity in combination with imatinib mesylate. Thus, the objectives to the study are (1) to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of lonafarnib (SCH66336), a farnesyl transferase inhibitor, in combination with imatinib mesylate (Gleevec) in patients with chronic phase, accelerated phase, and blast crisis CML; (2) to assess the pharmacokinetics of the combination of lonafarnib and Gleevec in these patients; and (3) to assess in a preliminary way the biologic activity of the combination of lonafarnib and Gleevec in these patients.