Last reviewed · How we verify
NCT02122770
Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors
Phase 1 trial testing MLN4924 in Advanced Solid Tumors in 51 participants. Completed in 5 June 2017.
5 June 2017
Quick facts
| Lead sponsor | Millennium Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 April 2014 |
| Primary completion | 5 June 2017 |
| Estimated completion | 5 June 2017 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- MLN4924
- Fluconazole
- Itraconazole — full drug profile →
- Docetaxel
- Carboplatin (Carboplatin) — full drug profile →
- Paclitaxel — full drug profile →
Conditions studied
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
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):
-
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 -
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 -
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 -
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 -
Targeting ubiquitination for cancer therapies.
Morrow JK, Lin HK, Sun SC, Zhang S. · · 2015 · cited 91× · PMID 26630263 · DOI 10.4155/fmc.15.148 -
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 -
Targeting the Ubiquitin-Proteasome System and Recent Advances in Cancer Therapy.
Spano D, Catara G. · · 2023 · cited 49× · PMID 38201233 · DOI 10.3390/cells13010029 -
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:
- PubMed search for NCT02122770
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MLN4924
Trials testing the same drug.
- NCT01862328 — Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in · Phase 1 · completed
- NCT01814826 — Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years · Phase 1 · completed
- NCT01415765 — MLN4924 Compared With MLN4924 Plus Chemotherapy for Large B-cell Lymphoma · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
- NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
- NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Millennium Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
- NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
- NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
- NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
- NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02122770 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
- Last refreshed: 7 January 2019
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