A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia
Myeloid and Monocytic Leukemia
What is the purpose of this trial?
This clinical trial is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of LAM-003 across a range of LAM 003 dose levels when administered to subjects with previously treated relapsed or refractory AML.
Subjects will self-administer oral LAM 003 either once or twice per day as long as they are safely benefitting from therapy. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of LAM 003 using a standard 3+3 dose-escalation design. Based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended LAM-003 dosing regimen.
- Trial withLAM Therapeutics, Inc.
- Start Date03/28/2018
- End Date08/31/2019
- Last Updated03/30/2018
- Study HIC#2000022212