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ONO-7475 3mg once daily for Acute Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Ono Pharmaceutical Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to maximum of 32 months
Awards & highlights

Summary

This trial is testing a new cancer drug, ONO-7475, to see if it is safe and works well against leukemia and myelodysplastic syndromes.

Eligible Conditions
  • Acute Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to maximum of 32 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to maximum of 32 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically Significant Changes in 12-Lead Electrocardiogram Parameters (Part A)
Clinically Significant Changes in Ophthalmology Examination Parameters (Part A)
Complete Response (CR) / Complete Response With Partial Hematologic Recovery (CRh) Rate (Part D)
+4 more
Secondary outcome measures
Determination of Maximum Tolerated Dose (MTD) by Assessing Dose Limiting Toxicities (DLT) (Part A)
Duration of Response in ONO-7475 + Venetoclax Group (Part D)
Event Free Survival in ONO-7475 Groups (Part A)
+20 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: ONO-7475 6mg once dailyExperimental Treatment1 Intervention
Part A 2nd dose level
Group II: ONO-7475 6mg + Venetoclax (70-400mg)Experimental Treatment1 Intervention
Part D ONO-7475 + Venetoclax combination
Group III: ONO-7475 3mg once dailyExperimental Treatment1 Intervention
Part A Initial dose level
Group IV: ONO-7475 10mg once dailyExperimental Treatment1 Intervention
Part A 3rd dose level

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Who is running the clinical trial?

Ono Pharmaceutical Co. LtdLead Sponsor
154 Previous Clinical Trials
94,481 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharmaceutical Co. Ltd
12 Previous Clinical Trials
2,571 Total Patients Enrolled
ONO Pharma UK LtdStudy DirectorDrug Development Division
~5 spots leftby Jul 2025
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