Clinical Trials
Sponsor:
Sponsor Study ID:
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
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).
Study Documents
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