Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04985656
Status:
WITHDRAWN
Last Update Posted:
2021-09-29
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 2, Open-Label Study of Intravenous Pevonedistat in Combination With Oral Decitabine and Cedazuridine in Adult Patients With Higher-Risk Myelodysplastic Syndromes
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision to Terminate Trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEVOBINE
Brief Summary:
The main aim of the study is to see if signs and symptoms of myelodysplastic syndromes disappear when treated with pevonedistat combined with decitabine and cedazuridine.
Participants will receive an infusion of pevonedistat 3 times during a 28-day cycle. They will also take decitabine and cedazuridine tablets once a day for the first 5 days of the same cycle. A minimum of 6 28-day cycles is recommended, but participants can stop treatment at any time.
A bone marrow biopsy, bone marrow aspirates, and blood samples will be collected during the study.
Participants will attend a follow-up visit 30 days after their last dose of pevonedistat. Once treatment has ended, participants will be followed up with either monthly clinic visits or will be contacted every 3 months.
Participants will receive an infusion of pevonedistat 3 times during a 28-day cycle. They will also take decitabine and cedazuridine tablets once a day for the first 5 days of the same cycle. A minimum of 6 28-day cycles is recommended, but participants can stop treatment at any time.
A bone marrow biopsy, bone marrow aspirates, and blood samples will be collected during the study.
Participants will attend a follow-up visit 30 days after their last dose of pevonedistat. Once treatment has ended, participants will be followed up with either monthly clinic visits or will be contacted every 3 months.
Detailed Description:
The drug being tested in this study is called Pevonedistat (TAK-924/MLN4924). Pevonedistat is being tested to treat people who have higher-risk myelodysplastic syndromes (HR MDS). This study will look at the overall survival, event free survival and response in people who take pevonedistat in combination with oral decitabine and cedazuridine in addition to standard care.
The study will enroll approximately 94 patients. Participants will be assigned to following treatment group:
• Pevonedistat 20 mg/m\^2 + Decitabine 35 mg + Cedazuridine 100 mg
All participants will receive pevonedistat in combination with decitabine and cedazuridine as specified in the protocol.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 30 months. Participants will make multiple visits to the clinic and will be contacted by telephone OR plus a final visit after receiving their last dose of drug/compound 30 days after last dose of study drug for event free survival (EFS) follow-up followed by overall survival (OS) follow-up.
The study will enroll approximately 94 patients. Participants will be assigned to following treatment group:
• Pevonedistat 20 mg/m\^2 + Decitabine 35 mg + Cedazuridine 100 mg
All participants will receive pevonedistat in combination with decitabine and cedazuridine as specified in the protocol.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 30 months. Participants will make multiple visits to the clinic and will be contacted by telephone OR plus a final visit after receiving their last dose of drug/compound 30 days after last dose of study drug for event free survival (EFS) follow-up followed by overall survival (OS) follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: