Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Official Title

A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.

Summary:

Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose [RP2D]).

Trial Description

Primary Outcome:

• Subject incidence of dose limiting toxicities (DLTs)
• Subject incidence of treatment-emergent adverse events (TEAEs)
• Subject incidence of treatment-related adverse events (TRAEs)

Secondary Outcome:

• Maximum observed concentration (Cmax) of AMG 427
• Minimum concentration (Cmin) of AMG 427
• Area under the concentration-time curve (AUC) of AMG 427
• Half Life (t1/2) of AMG 427
• Complete response/remission [CR]
• Complete response/remission with incomplete recovery of peripheral blood counts [CRi]
• Partial remission (per modified International Working Group IWG criteria)
• Morphologic leukemia-free state
• Complete remission with partial hematologic recovery (CRh)
• Duration of response
• Relapse free survival

Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose [RP2D]). Approximately 80 subjects will be enrolled.

View this trial on ClinicalTrials.gov