Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)
Sponsor: M.D. Anderson Cancer Center
This PHASE1 trial investigates Chronic Myelogenous Leukemia and is currently completed. M.D. Anderson Cancer Center leads this study, which shows 8 recorded versions since 2002 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
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Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Dec 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 3 earlier versions
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Jun 2018 — Dec 2018 [monthly]
Completed PHASE1
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Nov 2002
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- M.D. Anderson Cancer Center
For direct contact, visit the study record on ClinicalTrials.gov .