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NCT02122770

Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 7 January 2019
What this trial tests

Phase 1 trial testing MLN4924 in Advanced Solid Tumors in 51 participants. Completed in 5 June 2017.

Timeline
1 April 2014
Primary endpoint
5 June 2017
5 June 2017

Quick facts

Lead sponsorMillennium Pharmaceuticals, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment51
Start date1 April 2014
Primary completion5 June 2017
Estimated completion5 June 2017
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.

Publications & conference data

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

  1. Metabolism pathways of arachidonic acids: mechanisms and potential therapeutic targets.
    Wang B, Wu L, Chen J, Dong L, et al · · 2021 · cited 900× · PMID 33637672 · DOI 10.1038/s41392-020-00443-w
  2. Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
    Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209
  3. Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
    Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
  4. PRMT5-PTEN molecular pathway regulates senescence and self-renewal of primary glioblastoma neurosphere cells.
    Banasavadi-Siddegowda YK, Russell L, Frair E, Karkhanis VA, et al · · 2017 · cited 113× · PMID 27292259 · DOI 10.1038/onc.2016.199
  5. Targeting ubiquitination for cancer therapies.
    Morrow JK, Lin HK, Sun SC, Zhang S. · · 2015 · cited 91× · PMID 26630263 · DOI 10.4155/fmc.15.148
  6. PRMT5 as a druggable target for glioblastoma therapy.
    Banasavadi-Siddegowda YK, Welker AM, An M, Yang X, et al · · 2018 · cited 86× · PMID 29106602 · DOI 10.1093/neuonc/nox206
  7. Targeting the Ubiquitin-Proteasome System and Recent Advances in Cancer Therapy.
    Spano D, Catara G. · · 2023 · cited 49× · PMID 38201233 · DOI 10.3390/cells13010029
  8. The Next Frontier: Translational Development of Ubiquitination, SUMOylation, and NEDDylation in Cancer.
    Pellegrino NE, Guven A, Gray K, Shah P, et al · · 2022 · cited 48× · PMID 35408841 · DOI 10.3390/ijms23073480

Verify or expand the search:

Other trials of MLN4924

Trials testing the same drug.

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

Other Millennium Pharmaceuticals, Inc. 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/NCT02122770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing