Sponsor: Ono Pharmaceutical Co., Ltd.
Sponsor Study ID: ONO-7475-01
Study Title: A Phase I Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO 7475 in Patients with Acute Leukemias
CTO #: 102672
NCT Number: NCT03176277
Phase: I/II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Myeloid and Monocytic Leukemia
Study Objectives: Part A: The primary objective of this part of the study is to establish a safe and potentially clinically efficacious dose for further investigation in Parts B and C. The endpoints will be to monitor safety through evaluation of adverse events, changes in electroretinogram (ERG), ophthalmology examinations and 12-lead electrocardiogram (ECG). PK analysis and efficacy evaluations will also be conducted. Part B: The primary objective of this part of the study is to establish a safe dose of the combination of ONO-7475 and azacitidine in elderly de novo AML patients. The primary endpoints are incidence, nature, and severity of AEs and SAEs of ONO-7475, clinically significant changes in electroretinogram (ERG), ophthalmology examinations and 12-lead electrocardiogram (ECG). Part C: The primary objective of this part of the study is to establish a safe dose of ONO-7475 in ALL patients. The primary endpoints are incidence, nature, and severity of AEs and SAEs of ONO-7475, clinically significant changes in electroretinogram (ERG), ophthalmology examinations and 12-lead electrocardiogram (ECG).