NCT00047502

Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Lonafarnib (SCH66336)	Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive SCH66336 100 mg by mouth twice a day.
DRUG	Imatinib Mesylate (Gleevec)	Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day.

Timeline

• Start date: 2002-11-01
• Primary completion: 2006-04-10
• Completion: 2006-04-10
• First posted: 2002-10-09
• Last updated: 2018-11-07

Locations

1 site across 1 country: United States