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NCT03319537

Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma

Terminated Phase 1, PHASE2 Results posted Last updated 23 May 2024
What this trial tests

Phase 1, PHASE2 trial testing pevonedistat in Mesothelioma in 9 participants. Terminated before completion.

Timeline
5 October 2017
Primary endpoint
5 June 2023
5 June 2023

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment9
Start date5 October 2017
Primary completion5 June 2023
Estimated completion5 June 2023
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Mesothelioma. 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.

Number of Patients Who Have a Clinical Benefit Rate (CBR) (Cohort 1) Primary · at 18 weeks post initiation of treatment

The CBR is defined as the proportion of patients CR, PR or SD at 18 weeks based on RECIST criteria.

GroupValue95% CI
Pevonedistat2
Pevonedistat7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pevonedistat
Serious: 3/9 (33%)
Deaths: 8/9
Pevonedistat in Combination With Pemetrexed and Cisplatin
Serious: 0
Deaths: 0

Serious adverse events (4 terms)

ReactionSystemPevonedistatPevonedistat in Combinatio…
Upper Gastrointestinal HemorrhageGastrointestinal disorders——
Back PainMusculoskeletal and connective tissue disorders——
Neoplasms ben/mal/unk (inc cyst/polypNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Death NOSGeneral disorders——
Other adverse events (35 terms — click to expand)

ReactionSystemPevonedistatPevonedistat in Combinatio…
ConstipationGastrointestinal disorders——
FatigueGeneral disorders——
AnxietyPsychiatric disorders——
Back painMusculoskeletal and connective tissue disorders——
CoughRespiratory, thoracic and mediastinal disorders——
DyspneaRespiratory, thoracic and mediastinal disorders——
NauseaGastrointestinal disorders——
Abdominal PainGastrointestinal disorders——
AnorexiaMetabolism and nutrition disorders——
DiarrheaGastrointestinal disorders——
DizzinessNervous system disorders——
PainGeneral disorders——
Productive CoughRespiratory, thoracic and mediastinal disorders——
Rash maculo-papularSkin and subcutaneous tissue disorders——
Alanine aminotransferase increasedInvestigations——
Allergic rhinitisRespiratory, thoracic and mediastinal disorders——
Aspartate aminotransferase increasedInvestigations——
Chest wall painMusculoskeletal and connective tissue disorders——
ChillsGeneral disorders——
Decreased appetiteMetabolism and nutrition disorders——
DehydrationMetabolism and nutrition disorders——
Dry eyeEye disorders——
Edema limbsGeneral disorders——
FeverGeneral disorders——
FlatulenceGastrointestinal disorders——
Gastroesophageal reflux diseaseGastrointestinal disorders——
HeadacheNervous system disorders——
HypertensionVascular disorders——
InsomniaPsychiatric disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
Nasal congestionRespiratory, thoracic and mediastinal disorders——
Sinus tachycardiaCardiac disorders——
Sore throatRespiratory, thoracic and mediastinal disorders——
Upper respiratory infectionInfections and infestations——
VomitingGastrointestinal disorders——

Most-reported serious reactions: Upper Gastrointestinal Hemorrhage, Back Pain, Neoplasms ben/mal/unk (inc cyst/polyp, Death NOS.

Data from ClinicalTrials.gov NCT03319537 adverse events section.

Sponsor's own description

The purpose of this study is to test any good and bad effects of activity pevonedistat taken alone, and also to test the safety of pevonedistat in combination with standard chemotherapy, pemetrexed/cisplatin.

Publications & conference data

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

  1. 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
  2. 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
  3. 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
  4. 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
  5. Harnessing DNA Replication Stress for Novel Cancer Therapy.
    Zhu H, Swami U, Preet R, Zhang J. · · 2020 · cited 30× · PMID 32854236 · DOI 10.3390/genes11090990
  6. NF2: An underestimated player in cancer metabolic reprogramming and tumor immunity.
    Xu D, Yin S, Shu Y. · · 2024 · cited 20× · PMID 38879686 · DOI 10.1038/s41698-024-00627-5
  7. Target Therapy in Malignant Pleural Mesothelioma: Hope or Mirage?
    Borea F, Franczak MA, Garcia M, Perrino M, et al · · 2023 · cited 12× · PMID 37298116 · DOI 10.3390/ijms24119165
  8. The Double-Edged Effects of MLN4924: Rethinking Anti-Cancer Drugs Targeting the Neddylation Pathway.
    Tang H, Pang X, Li S, Tang L. · · 2024 · cited 11× · PMID 39062453 · DOI 10.3390/biom14070738

Verify or expand the search:

Other recruiting trials for Mesothelioma

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center 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/NCT03319537.

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