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Anti-tumor Antibiotic

ASP7517 for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
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 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ASP7517, to see if it is safe and effective. The trial will also determine the best dose of the drug to give to patients.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete remission + bone marrow complete remission + partial remission (CR + BM CR + PR) rate for participants with R/R higher risk MDS (phase 2)
Composite complete remission (CRc) rate for participants with R/R AML (phase 2)
Incidence of dose limiting toxicities (DLTs)
+7 more
Secondary outcome measures
Best response (CRc + PR) rates for participants with R/R AML
CR rates for participants with R/R AML
CR rates for participants with R/R higher risk MDS
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 ASP7517 Dose ExpansionExperimental Treatment1 Intervention
Up to six single doses of ASP7517 will be administered intravenously at the dose levels determined from the Dose Escalation phase.
Group II: Phase 1 ASP7517 Dose EscalationExperimental Treatment1 Intervention
Two single doses of ASP7517 will be administered intravenously at up to 3 dose levels and will be based on the assessment of safety variables, including the occurrence of dose limiting toxicities (DLTs).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASP7517
2019
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,043 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,064,176 Total Patients Enrolled

Frequently Asked Questions

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

What is the capacity of this clinical trial to accept participants?

"Yes, the information on clinicaltrials.gov affirms that this medical experiment is actively recruiting patients. It was initially posted on September 19th 2019 and recently updated on November 16th 2022 with a goal of 122 participants across 8 different sites."

Answered by AI

What goals is this research endeavor attempting to accomplish?

"The overarching goal of this two-year trial is to track the laboratory value abnormalities and adverse events experienced by enrolled patients. Secondary objectives include ascertaining duration of remission for those with acute myeloid leukaemia (AML), CRh rates for participants with relapsed/refractory AML, and event-free survival rate among all study enrollees."

Answered by AI

Is there still room to enroll in this experiment?

"As per clinicaltrials.gov, this trial is currently enrolling patients and was first published on the 19th of September in 2019 with its most recent update taking place on November 16th 2022."

Answered by AI

How many health care facilities are currently administering this trial?

"NYU Langone Health in New york, Northside Hospital Cancer Institute in Atlanta, and City of Hope in Duarte are all participating sites for this study. In addition, 8 other clinical trial locations across the nation are enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
2019. "A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04079296.
~8 spots leftby Apr 2025
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