NCT03426605

A Study of LAM-003 in Patients With Acute Myeloid Leukemia

A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: OrphAI Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia

Detailed description

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 cute Myeloid Leukemia (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.

Conditions

• Oncology
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Open Label LAM-003	LAM-003

Timeline

• Start date: 2018-01-16
• Primary completion: 2020-02-20
• Completion: 2020-10-05
• First posted: 2018-02-08
• Last updated: 2024-05-03
• Results posted: 2024-05-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study