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Therapy Name Azacitidine + MLN4924
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Azacitidine Vidaza azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg DNMT inhibitor (Pan) 5 Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).
MLN4924 Pevonedistat MLN-4924 Pevonedistat (MLN4924) binds and inhibits NEDD8, a ubiquitin-like protein, leading to inhibition of NFKB signaling, reduced transcription of target genes, and increased apoptosis in cancer cells with increased NFKB activity (PMID: 24634471, PMID: 29781056, PMID: 32721435).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04712942 Phase II Azacitidine + MLN4924 Azacitidine Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat Completed DEU 0
NCT03814005 Phase I Azacitidine + MLN4924 A Study of Pevonedistat in Combination With Azacitidine in Participants With Higher-risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myelogenous Leukemia (AML) With Severe Renal Impairment or Mild Hepatic Impairment Completed USA | ESP 0
NCT03745352 Phase II Azacitidine Azacitidine + MLN4924 Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Withdrawn 0
NCT03268954 Phase III Azacitidine + MLN4924 Azacitidine Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) (PANTHER) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 11
NCT04090736 Phase III Azacitidine Azacitidine + MLN4924 Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy (PEVOLAM) Active, not recruiting ESP 1
NCT03238248 Phase II Azacitidine + MLN4924 Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors Active, not recruiting USA 0
NCT03709576 Phase II Azacitidine + MLN4924 Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML Terminated USA 0


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