Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047502
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2002-10-08
Brief Title:
Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Lonafarnib SCH66336 and Gleevec Imatinib Mesylate in Chronic Myelogenous Leukemia CML
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inhibitorexhibits 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None