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ONO-7475 3mg once daily for Myelodysplastic Syndrome

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
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new drug, ONO-7475, alone and with another drug, venetoclax, in patients with certain blood cancers that have not responded to other treatments. The drugs work by trying to stop cancer cells from growing and making them die. Venetoclax is used in treating lymphomas and leukemias, but it is known for its severe side effects.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Acute Leukemia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
171 Previous Clinical Trials
95,694 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharmaceutical Co. Ltd
25 Previous Clinical Trials
3,371 Total Patients Enrolled
ONO Pharma UK LtdStudy DirectorDrug Development Division
~5 spots leftby Nov 2025
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