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Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes

NCT04484363 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2022-09-30

No results posted yet for this study

Summary

Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available.

The main aim of this program is to allow participants to have access to pevonedistat before FDA approval.

This program will take place in the United States.

Conditions

Interventions

DRUG

Pevonedistat

Pevonedistat 20 milligram per square meter (mg/m\^2), intravenous infusion, on Days 1, 3, and 5 of repeated 28-day cycles.

DRUG

Azacitidine

Azacitidine 75 mg/m\^2, intravenous or subcutaneous infusion, on Days 1 to 5, Days 8 and 9 of repeated 28-day cycles or Days 1 through 7 of repeated 28-day cycles.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484363 on ClinicalTrials.gov