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A Study of ONO-7475 in Patients With Acute Leukemias
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to maximum of 32 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to maximum of 32 months
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 moreSecondary 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 moreAwards & 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
174 Previous Clinical Trials
95,896 Total Patients Enrolled
Project LeaderStudy DirectorOno Pharmaceutical Co. Ltd
27 Previous Clinical Trials
3,545 Total Patients Enrolled
ONO Pharma UK LtdStudy DirectorDrug Development Division