Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity (DLT)
Dose-Limiting Toxicity (DLT) defined as grade 3 or 4 non-hematologic toxicity (NCI common criteria, version 2.0). Grade 3 or 4 nausea and vomiting considered DLT only if uncontrolled by antiemetics. Grade 3 or 4 diarrhea considered DLT only if uncontrolled for 48 hours despite adequate antidiarrheal therapy.
3 months
No
Jorge E. Cortes, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
ID02-221
NCT00047502
November 2002
April 2006
Name | Location |
---|---|
M.D. Anderson Cancer Center | Houston, Texas 77030 |