At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
Azacitidine Subcutaneous Injection or Intravenous Infusion +2 moredrug
Likely dose
Azacitidine Subcutaneous Injection or Intravenous Infusion 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
In Brief
A Phase 2 clinical trial evaluating Azacitidine Subcutaneous Injection or Intravenous Infusion, Pevonedistat Infusion, and 1 other intervention for Myelodysplastic Syndromes and Myeloproliferative Neoplasm. Completed, enrolled 71 participants across 5 sites.
Detailed Summary
This study will evaluate the treatment combination of pevonedistat and azacitidine in the setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartAug 2017
Primary CompletionSep 2022
Study CompletionNov 2023
TodayJul 2026
First PostedAug 3, 2017
Enrollment StartAug 7, 2017
Primary CompletionSep 30, 2022
Study CompletionNov 27, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.9 years ago
Interventions
Azacitidine Subcutaneous Injection or Intravenous Infusiondrug
75 mg/m2
Pevonedistat Infusiondrug
20 mg/m2
Bone Marrow Biopsy & Aspirateprocedure
Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.