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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society