Trial reportInvestigational new drugs2016
An open-label, single-arm, phase 2 study of the Aurora kinase A inhibitor alisertib in patients with advanced urothelial cancer.
Trial report in Investigational new drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02109328 (A Phase 2 Study of the Aurora Kinase A Inhibitor Alisertib), which is not on this map. Cited by 16 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2 Study of the Aurora Kinase A Inhibitor Alisertib (MLN8237) in Patients With Relapsed or Refractory Transitional-cell Carcinoma of the Bladder and Urothelial Tract
Who cites it
16 citing papers in PubMed, 26 citations in OpenAlex.
- Epigenomics-Guided Multi-Omics Integration Uncovers a Lipid-Metabolic Signature with Translational Utility in Bladder Cancer.Computational and structural biotechnology journal · 2026Article
- Research progress on the relationship between AURKA and tumorigenesis: the neglected nuclear function of AURKA.Annals of medicine · 2024Review
- Article
- The two sides of chromosomal instability: drivers and brakes in cancer.Signal transduction and targeted therapy · 2024Review
- Clinical outcomes associated with expression of aurora kinase and p53 family members in muscle-invasive bladder cancer.Molecular and clinical oncology · 2022Article
- Second-Generation Antimitotics in Cancer Clinical Trials.Pharmaceutics · 2021Review
- Next-generation sequencing reveals novel mutations in a collision tumor of glioblastoma and meningioma.CNS oncology · 2021Article
- Antitumor Effect of Lenvatinib Combined with Alisertib in Hepatocellular Carcinoma by Targeting the DNA Damage Pathway.BioMed research international · 2021Article
- The role of Aurora-A in human cancers and future therapeutics.American journal of cancer research · 2020Review
- TAF1L promotes development of oral squamous cell carcinoma via decreasing autophagy-dependent apoptosis.International journal of biological sciences · 2020Article
- Therapeutic Rationale to Target Highly Expressed Aurora kinase A Conferring Poor Prognosis in Cholangiocarcinoma.Journal of Cancer · 2020Article
- Activation of Aurora A kinase increases YAP stability via blockage of autophagy.Cell death & disease · 2019Article
- Proteomics analysis of bladder cancer invasion: Targeting EIF3D for therapeutic intervention.Oncotarget · 2017Article
- Advances of small molecule targeting of kinases.Current opinion in chemical biology · 2017Review
- Association of an aurora kinase a (AURKA) gene polymorphism with progression-free survival in patients with advanced urothelial carcinoma treated with the selective aurora kinase a inhibitor alisertib.Investigational new drugs · 2017Article
- Bladder Cancer-related microRNAs With In Vivo Efficacy in Preclinical Models.Cancer diagnosis & prognosisReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProgress in developing effective salvage therapies for UC is warranted. Alisertib is an orally available, selective inhibitor of the aurora kinase A.
methodsA single-group, phase 2 trial was conducted with alisertib 50 mg orally BID for 7 days, with 14d rest until disease progression (PD) (NCT02109328). The primary endpoint (EP) was RECIST 1.1 objective response-rate (ORR, H0 ≤ 5%, H1 ≥ 20%, α = 10% and β = 20%). Eligibility included failure of at least one platinum-based regimen.
resultsFrom 10/2014 to 04/2015, 22 patients were enrolled (20 evaluable for response), 8 (36.4%) in second-line and 14 (63.6 %) beyond the second-line. Eight (36.4%) had an ECOG-performance status 1-2. Two partial responses (PR, ORR: 9.1%), 7 stable disease (SD) and 11 PD were obtained. Median follow-up was 8.3 months (IQR: 7-10.3), 6-month progression-free survival (PFS) was 13.6% (95%CI: 4.8-39.0). Two SD are still receiving treatment after 11.5 and 6.3 months. Median overall survival (OS) was not reached (6-month OS: 59.1%, 95%CI: 41.7-83.7). Hb < 10 g/dl was significantly associated with shorter PFS and OS multivariably (p = 0.031 and p = 0.033). Tissue of the case with 11.5 month SD harbored a missense mutation of mTOR (E1813D), the nonsense mutation Q527STOP of TSC1, HER3 and TAF1L missense mutations. Grade 3-4 adverse events (AE) were: 40.9% mucositis, 36.4% fatigue, 18.2% neutropenia (13.6% febrile neutropenia). There were 2 treatment-related deaths.
conclusionsThe study did not meet the primary EP, yet sustained disease control was obtained in about 14% of patients. The incidence of AE and the issue of patient selection are two major concerns.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.