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NCT04172844: PAVE

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Terminated Phase 1 Last updated 4 June 2024
What this trial tests

Phase 1 trial testing Azacitidine in Acute Myelogenous Leukemia in 16 participants. Terminated before completion.

Timeline
13 January 2020
Primary endpoint
12 December 2021
27 February 2022

Quick facts

Lead sponsorMedical College of Wisconsin
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment16
Start date13 January 2020
Primary completion12 December 2021
Estimated completion27 February 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase Ib study with a 3 + 3 dose escalation design followed by a dose-expansion phase.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting NEDD8-activating enzyme for cancer therapy: developments, clinical trials, challenges and future research directions.
    Fu DJ, Wang T. · · 2023 · cited 45× · PMID 37525282 · DOI 10.1186/s13045-023-01485-7
  2. Transcription Factors: The Fulcrum Between Cell Development and Carcinogenesis.
    Islam Z, Ali AM, Naik A, Eldaw M, et al · · 2021 · cited 38× · PMID 34195082 · DOI 10.3389/fonc.2021.681377
  3. Targeting cullin neddylation for cancer and fibrotic diseases.
    He ZX, Yang WG, Zengyangzong D, Gao G, et al · · 2023 · cited 33× · PMID 37771770 · DOI 10.7150/thno.78876
  4. Deciphering the role of neddylation in tumor microenvironment modulation: common outcome of multiple signaling pathways.
    Liu D, Che X, Wu G. · · 2024 · cited 25× · PMID 38191508 · DOI 10.1186/s40364-023-00545-x
  5. Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.
    El-Cheikh J, Bidaoui G, Saleh M, Moukalled N, et al · · 2023 · cited 22× · PMID 37071328 · DOI 10.1007/s44228-023-00041-x
  6. A phase I study of pevonedistat, azacitidine, and venetoclax in patients with relapsed/refractory acute myeloid leukemia.
    Murthy GSG, Saliba AN, Szabo A, Harrington A, et al · · 2024 · cited 17× · PMID 38572562 · DOI 10.3324/haematol.2024.285014
  7. Pevonedistat with azacitidine in older patients with TP53-mutated AML: a phase 2 study with laboratory correlates.
    Saliba AN, Kaufmann SH, Stein EM, Patel PA, et al · · 2023 · cited 16× · PMID 36315007 · DOI 10.1182/bloodadvances.2022008625
  8. Advances in therapeutic options for newly diagnosed, high-risk AML patients.
    Doucette K, Karp J, Lai C. · · 2021 · cited 16× · PMID 33995985 · DOI 10.1177/20406207211001138

Verify or expand the search:

Other trials of Azacitidine

Trials testing the same drug.

Other recruiting trials for Acute Myelogenous Leukemia

Currently open trials in the same condition.

Other Medical College of Wisconsin trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04172844.

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