Trials / Terminated
TerminatedNCT03176277
A Study of ONO-7475 in Patients With Acute Leukemias
A Phase I/II Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias or Myelodysplastic Syndromes
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Part A is a dose escalation study of ONO-7475 in patients with acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes. Part D is a dose escalation study of ONO-7475 in combination with venetoclax. ONO-7475 starting dose is selected following safety and tolerability outcome of Part A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-06-26
- Primary completion
- 2022-12-01
- Completion
- 2023-01-20
- First posted
- 2017-06-05
- Last updated
- 2024-07-15
- Results posted
- 2024-05-16
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03176277. Inclusion in this directory is not an endorsement.