Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)

Summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML). For enrollment information see the Central Contact information below

Timeline

Start

2007-07

Primary completion

—

Completion

2009-07

Outcome

Missed primary endpoint

Stopped: “AML assess. of response in Part B patients find treatment failure in all 8 evaluable for marrow response following a maximum of 2 induction courses of therapy”

paper No evaluable patients experienced a complete remission (CR) or CR with incomplete blood count recovery (CRi), demonstrating no evidence of AZD4877 efficacy in this population. PMID 21494838 ↗

paper This study was terminated due to lack of efficacy. PMID 21494838 ↗

Publications

• Kantarjian HM, Padmanabhan S, Stock W, Tallman MS, Curt GA, Li J, Osmukhina A, Wu K, Huszar D, Borthukar G, Faderl S, Garcia-Manero G, Kadia T, Sankhala K, Odenike O, Altman JK, Minden M. Phase I/II multicenter study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD4877 in patients with refractory acute myeloid leukemia. Invest New Drugs. 2012 Jun;30(3):1107-15. doi: 10.1007/s10637-011-9660-2. Epub 2011 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZD4877	Small molecule	2 mg	Intravenous
Subject	AZD4877	Small molecule	4 mg	Intravenous
Subject	AZD4877	Small molecule	7 mg	Intravenous
Subject	AZD4877	Small molecule	10 mg	Intravenous
Subject	AZD4877	Small molecule	13 mg	Intravenous
Subject	AZD4877	Small molecule	16 mg	Intravenous
Subject	AZD4877	Small molecule	18 mg	Intravenous

Indications