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Brief Title: Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia
Official Title: A Phase 1/2, Open-Label, Multi-Center Dose Escalation, Safety and Tolerability Study of AKN-028 in Patients With Acute Myelogenous Leukemia (AML)
Study ID: NCT01573247
Brief Summary: This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Brno, Brno, , Czech Republic
University Hospital Kralovske Vinohrady, Prague, , Czech Republic
MTZ Clinical Research Inc., Warsaw, , Poland
Institute of Hematology and Transfusion Medicine, Warsaw, , Poland
Sahlgrenska University Hospital, Gothenburg, , Sweden
Orebro University Hospital, Orebro, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
St.Bartholomew's Hospital, West Smithfield, , United Kingdom
Name: Martin Höglund, MD, PhD
Affiliation: Dept of Hematology, Uppsala University Hospital
Role: PRINCIPAL_INVESTIGATOR