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A Study of ONO-7475 in Patients With Acute Leukemias

NCT03176277 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-07-15

Study results available
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Summary

\[Updated\]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.

Conditions

Interventions

DRUG

ONO-7475 3mg once daily

Part A initial dose level

DRUG

ONO-7475 6mg once daily

Part A 2nd dose level

DRUG

ONO-7475 10mg once daily

Part A 3rd dose level

DRUG

ONO-7475 6mg + Venetoclax (70-400mg)

Part D ONO-7475 + Venetoclax Combination

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2022-12-01
Completion
2023-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176277 on ClinicalTrials.gov