Therapy Detail
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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 |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT03745352 | Phase II | Azacitidine Azacitidine + MLN4924 | Pevonedistat With Azacitidine Versus Azacitidine Alone in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | Withdrawn | 0 | |
| 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) | Unknown status | 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 | Completed | USA | 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) | Completed | USA | TUR | POL | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | 5 |
| 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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