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ONO-7475 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 up to 12 months
Awards & highlights

Study 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 ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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 electrocardiogram (ECG) (Part A)
Clinically significant ophthalmology examinations (Part A)
Complete response (CR)/complete response with partial hematologic recovery (CRh) rate (Part D)
+2 more
Secondary outcome measures
Complete Response (Part A and D)/ Complete Response with partial hematologic recovery without minimal residual disease (MRD) AML (Part D only)
Complete Response rate (Part D)
Complete response with partial hematologic recovery rate (Part D)
+30 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: ONO-7475 + venetoclax (Part D)Experimental Treatment1 Intervention
Successive dose escalation of ONO-7475 cohorts + venetoclax
Group II: ONO-7475 (Part A)Experimental Treatment1 Intervention
Successive dose escalation cohorts to determine MTD/OBD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONO-7475
2018
Completed Phase 1
~30

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives does this research endeavor hope to achieve?

"This clinical trial will run for up to 12 months and its primary objective is to assess the incidence, nature, and severity of adverse events stemming from ONO-7475. Secondary objectives include determining the drug's elimination half-life; assessing the time taken for maximum plasma concentration; and establishing a Maximum Tolerated Dose (MTD)."

Answered by AI

How many individuals are being selected to partake in this medical trial?

"This medical trial is no longer taking on new participants. The first posting was on June 26th 2017 and the most recent update occurred in July 25th 2022. Thankfully, there are many other clinical studies that may be of interest to you; 2732 trials for myelodysplastic syndromes, and 219 specifically involving ONO-7475 are currently recruiting patients."

Answered by AI

How many sites in this state are undertaking the research project?

"At present, patients can join this medical trial at 16 distinct sites. Los Angeles, Louisville and Gainesville are three of the locations that offer it; there are also 13 other cities with participating centres for those who wish to minimize their travel commitments."

Answered by AI

Is this research endeavor currently enrolling participants?

"According to the clinicaltrials.gov database, this medical trial is not currently recruiting patients; it was first posted on June 26th 2017 and last updated on July 25th 2022. However, potential participants have a variety of other trials to consider as there are over 2,951 studies actively enrolling volunteers at present."

Answered by AI

What other experiments have used ONO-7475 for research purposes?

"Currently, 219 clinical trials for ONO-7475 are being conducted. Of those, 28 have reached Phase 3 of their research process. Most sites hosting these studies can be found in Boston, Massachusetts; though there is a network of 7198 different medical centres testing the treatment across multiple states."

Answered by AI
~5 spots leftby Apr 2025