Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Actual Study Start Date: October 9, 2013
Actual Primary Completion Date: August 4, 2017
Actual Study Completion Date: March 7, 2018

Arms:
- Experimental: Gilteritinib 20 mg in Escalation Phase
- Experimental: Gilteritinib 40 mg in Escalation Phase
- Experimental: Gilteritinib 80 mg in Escalation Phase
- Experimental: Gilteritinib 120 mg in Escalation Phase
- Experimental: Gilteritinib 200 mg in Escalation Phase
- Experimental: Gilteritinib 300 mg in Escalation Phase
- Experimental: Gilteritinib 450 mg in Escalation Phase
- Experimental: Gilteritinib 20 mg in Expansion Phase
- Experimental: Gilteritinib 40 mg in Expansion Phase
- Experimental: Gilteritinib 80 mg in Expansion Phase
- Experimental: Gilteritinib 120 mg in Expansion Phase
- Experimental: Gilteritinib 200 mg in Expansion Phase
- Experimental: Gilteritinib 300 mg in Expansion Phase