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NCT03176277 · ClinicalTrials.gov registry record · Phase 1
A Study of ONO-7475 in Patients With Acute Leukemias
A Phase 1 study, sponsored by Ono Pharmaceutical Co..
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03176277: Clinical Trial Phase 1 study, sponsored by Ono Pharmaceutical Co..
NCT03176277 is a Phase 1 study that was terminated before completion, run by Ono Pharmaceutical Co.. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03176277, a Phase 1 study, was terminated before completion, sponsored by Ono Pharmaceutical Co..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of most common (frequency of \>20%) treatment-emergent adverse events (TEAEs) of CTCAE grade 3 or higher by preferred terms coded with MedDRA version 23.1. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Interventions
- DRUG ONO-7475 3mg once daily
- DRUG ONO-7475 6mg once daily
- DRUG ONO-7475 10mg once daily
- DRUG ONO-7475 6mg + Venetoclax (70-400mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2023-01-20 |
| Phase | Phase 1 |
Why NCT03176277 stopped before completion
NCT03176277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which ONO-7475 3mg once daily is the first listed.
NCT03176277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03176277 about?
NCT03176277 is a clinical study titled "A Study of ONO-7475 in Patients With Acute Leukemias". \[Updated\]: 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 vene...
What is the current status of trial NCT03176277?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2017-06-26. Estimated completion is 2023-01-20.
What interventions are being tested in trial NCT03176277?
The interventions under investigation include: ONO-7475 3mg once daily (DRUG), ONO-7475 6mg once daily (DRUG), ONO-7475 10mg once daily (DRUG), ONO-7475 6mg + Venetoclax (70-400mg) (DRUG).
Who is sponsoring clinical trial NCT03176277?
This trial is sponsored by Ono Pharmaceutical Co., which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03176277's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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