Who is sponsoring NCT03057366?

NCT03057366 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT03057366?

Interventions in NCT03057366: Pevonedistat, [14C]-Pevonedistat, Docetaxel, Carboplatin, Paclitaxel.

What condition does NCT03057366 study?

NCT03057366 studies Advanced Solid Tumors, Neoplasms, Advanced Solid.

Is NCT03057366 still recruiting?

NCT03057366 is currently completed. Last updated 18 November 2019.

Are results published for NCT03057366?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-18 · How we verify

NCT03057366

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of [14 C]-Pevonedistat in Participants With Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 18 November 2019

What this trial tests

Phase 1 trial testing Pevonedistat in Advanced Solid Tumors, Neoplasms, Advanced Solid in 8 participants. Completed in 5 November 2018.

Timeline

11 May 2017

Primary endpoint
8 February 2018

5 November 2018

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	other
Enrollment	8
Start date	11 May 2017
Primary completion	8 February 2018
Estimated completion	5 November 2018
Sites	2 locations across Hungary

Drugs / interventions tested

Pevonedistat
[14C]-Pevonedistat
Docetaxel (Docetaxel) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Paclitaxel — full drug profile →

Conditions studied

Advanced Solid Tumors, Neoplasms, Advanced Solid — all drugs for Advanced Solid Tumors, Neoplasms, Advanced Solid →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	234.3	± 99.52

Whole blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	6862.9	± 1595.22

Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	0.980	0.95 – 1.50

Whole Blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	1.000	0.98 – 1.53

Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	1446.9	± 374.46

Whole Blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	59284.0	± 10035.58

Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	293.6	± 113.17

Whole Blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	7336.6	± 1270.99

Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	0.980	0.95 – 1.50

Whole Blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	0.980	0.98 – 2.00

Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Plasma

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	3547.3	± 1106.56

Whole Blood

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	133259.0	± 32678.72

Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	19661.05	± 4099.981

Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	25029.45	± 4333.04

Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	44690.50	± 2090.833

Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	1161.47	± 266.413

Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	2.45	± 0.548

Part A: Renal Clearance (CLR) for Pevonedistat Primary · Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Group	Value	95% CI
Part A: [14C]-Pevonedistat 25 mg/m^2	0.8343	± 0.27889

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (From first dose of study drug in Part A up to Day 31; From first dose of study drug in Part B up to Cycle 11 Day 35). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: [14C]-Pevonedistat 25 mg/m^2

Serious: 1/8 (13%)

Deaths: 1/8

Part B: Pevonedistat + Paclitaxel and Carboplatin

Serious: 2/5 (40%)

Deaths: 1/5

Part B: Pevonedistat + Docetaxel

Serious: 1/2 (50%)

Deaths: 1/2

Serious adverse events (4 terms)

Reaction	System	Part A: [14C]-Pevonedistat…	Part B: Pevonedistat + Pac…	Part B: Pevonedistat + Doc…
SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
FIBROSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
PNEUMONIA	Infections and infestations	—	—	—
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	—	—	—

Other adverse events (40 terms — click to expand)

Reaction	System	Part A: [14C]-Pevonedistat…	Part B: Pevonedistat + Pac…	Part B: Pevonedistat + Doc…
Vomiting	Gastrointestinal disorders	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Urinary Retention	Renal and urinary disorders	—	—	—
Abdominal Distension	Gastrointestinal disorders	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—
Oedema Peripheral	General disorders	—	—	—
Chest Pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Swelling	General disorders	—	—	—
Chills	General disorders	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—
Platelet Count Decreased	Investigations	—	—	—
Blood Creatinine Increased	Investigations	—	—	—
Blood Urea Increased	Investigations	—	—	—
Weight Decreased	Investigations	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Oral Herpes	Infections and infestations	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Bone Pain	Musculoskeletal and connective tissue disorders	—	—	—
Mueller's Mixed Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Conjunctival Haemorrhage	Eye disorders	—	—	—
Spinal Compression Fracture	Injury, poisoning and procedural complications	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Peripheral Venous Disease	Vascular disorders	—	—	—

Most-reported serious reactions: SARCOMA, FIBROSARCOMA, PNEUMONIA, GENERAL PHYSICAL HEALTH DETERIORATION.

Data from ClinicalTrials.gov NCT03057366 adverse events section.

Sponsor's own description

The purpose of this study is to assess the mass balance (that is, cumulative excretion of total radioactivity \[TRA\] in urine and feces) and to characterize the pharmacokinetics (PK) of pevonedistat in whole blood, plasma, and urine, and of TRA in plasma and whole blood following a single 1-hour infusion of 25 milligram per square meter (mg/m\^2) \[14C\]-pevonedistat intravenous (IV) solution containing approximately 60 to 85 microcurie (mCi) (approximately 2.22-3.145 megabecquerel \[MBq\]) of TRA in participants with advanced solid tumors in Part A.

Publications & conference data

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

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
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
Autophagy Agents in Clinical Trials for Cancer Therapy: A Brief Review.
Mohsen S, Sobash PT, Algwaiz GF, Nasef N, et al · · 2022 · cited 71× · PMID 35323341 · DOI 10.3390/curroncol29030141
Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumors.
Lockhart AC, Bauer TM, Aggarwal C, Lee CB, et al · · 2019 · cited 65× · PMID 29781056 · DOI 10.1007/s10637-018-0610-0
Unlocking the NF-κB Conundrum: Embracing Complexity to Achieve Specificity.
Begalli F, Bennett J, Capece D, Verzella D, et al · · 2017 · cited 51× · PMID 28829404 · DOI 10.3390/biomedicines5030050
Targeting the Ubiquitin-Proteasome System and Recent Advances in Cancer Therapy.
Spano D, Catara G. · · 2023 · cited 49× · PMID 38201233 · DOI 10.3390/cells13010029
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
Chromatin-Bound Cullin-Ring Ligases: Regulatory Roles in DNA Replication and Potential Targeting for Cancer Therapy.
Jang SM, Redon CE, Aladjem MI. · · 2018 · cited 34× · PMID 29594129 · DOI 10.3389/fmolb.2018.00019

Verify or expand the search:

Other trials of Pevonedistat

Trials testing the same drug.

NCT04985656 — A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes · Phase 2 · withdrawn
NCT04800627 — Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor · Phase 1, PHASE2 · terminated
NCT04712942 — Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat · Phase 2 · completed
NCT04266795 — A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable · Phase 2 · completed
NCT03965689 — Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell · Phase 2 · active not 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
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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03057366 (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: 18 November 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/NCT03057366.

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

NCT03057366

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Pevonedistat

Other Millennium Pharmaceuticals, Inc. trials

Verify against primary sources