Evidence map›Paper›PMID 30777875›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

A Phase II Study of Alisertib in Children with Recurrent/Refractory Solid Tumors or Leukemia: Children's Oncology Group Phase I and Pilot Consortium (ADVL0921).

Yael P Mossé, Elizabeth Fox, David T Teachey, Joel M Reid, Stephanie L Safgren, Hernan Carol, Richard B Lock, Peter J Houghton, Malcolm A Smith, David Hall and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01154816 (A Phase II Study of MLN8237, a Selective Aurora A Kinase Inhibitor in Children With Recurrent/Refractory Solid Tumors and Leukemias), which is not on this map. Cited by 65 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01154816 phase2completednot on this map

A Phase II Study of MLN8237, a Selective Aurora A Kinase Inhibitor in Children With Recurrent/Refractory Solid Tumors and Leukemias

TypeinterventionalSponsorChildren's Oncology GroupRan2011 to 2019Enrolled118ConditionsHepatoblastoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid LeukemiaArmsAlisertib, Laboratory Biomarker Analysis, Pharmacological Study
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 1 synthesis or guideline pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  6. Targeted and molecular therapies in Ewing sarcoma: a comprehensive review of preclinical and clinical advances.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  9. Article
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  11. Article
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  16. Histone Phosphorylation in DNA Damage Response.International journal of molecular sciences · 2025
    Review
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  18. Article
  19. Review
  20. Molecular regulation and therapeutic targeting ofFrontiers in cell and developmental biology · 2025
    Review

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 3 countries.

Yael P MosséDivision of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Pennsylvania. mosse@chop.edu.
Elizabeth FoxDivision of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Pennsylvania.
David T TeacheyDivision of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Pennsylvania.ORCID 0000-0003-1257-2316
Joel M ReidMayo Clinic, Rochester, Minnesota.
Stephanie L SafgrenMayo Clinic, Rochester, Minnesota.
Hernan CarolChildren's Cancer Institute, Lowy Cancer Research Centre, UNSW Sydney, Sydney, Australia.
Richard B LockChildren's Cancer Institute, Lowy Cancer Research Centre, UNSW Sydney, Sydney, Australia.
Peter J HoughtonGreehey Children's Cancer Research Institute, University of Texas Health Science Center San Antonio, San Antonio, Texas.
Malcolm A SmithCancer Therapy Evaluation Program, NCI, Bethesda, Maryland.ORCID 0000-0001-9880-9876
David HallChildren's Oncology Group, Monrovia, California.
Donald A BarkauskasChildren's Oncology Group, Monrovia, California.
Mark KrailoDepartment of Preventive Medicine, University of Southern California, Los Angeles, California.
Stephan D VossDana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts.
Stacey L BergTexas Children's Cancer Center, Baylor College of Medicine, Houston, Texas.ORCID 0000-0003-2832-9994
Susan M BlaneyTexas Children's Cancer Center, Baylor College of Medicine, Houston, Texas.
Brenda J WeigelDana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts.
Children's Hospital of Philadelphia · USCancer Institute of New South Wales · AUChildren's Cancer Center · USChildren's Oncology Group · CHDana-Farber/Boston Children's Cancer and Blood Disorders Center · USMayo Clinic · USThe University of Texas Health Science Center at San Antonio · USTracer Technologies (United States) · USUniversity of Southern California · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
PEP-CTN EHR to RAVE supplementUM1CA228823 · NCI · PUBLIC HEALTH INSTITUTE · PI Elizabeth Fox · 2018 to 2026
$39.6M
Pediatric Phase 1/Pilot ConsortiumUM1CA097452 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI WEIGEL, BRENDA J. · 2009 to 2018
$17.7M
NCI NIH HHS N01 CM042216NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UM1 CA097452NCI NIH HHS UM1 CA228823
6 · The paper itself

Abstract

purposeAurora A kinase (AAK) plays an integral role in mitotic entry, DNA damage checkpoint recovery, and centrosome and spindle maturation. Alisertib (MLN8237) is a potent and selective AAK inhibitor. In pediatric preclinical models, antitumor activity was observed in neuroblastoma, acute lymphoblastic leukemia, and sarcoma xenografts. We conducted a phase 2 trial of alisertib in pediatric patients with refractory or recurrent solid tumors or acute leukemias (NCT01154816). PATIENTS AND

methodsAlisertib (80 mg/m

resultsA total of 139 children and adolescents (median age, 10 years) were enrolled, 137 were evaluable for response. Five objective responses were observed (2 complete responses and 3 partial responses). The most frequent toxicity was myelosuppression. The median alisertib trough concentration on day 4 was 1.3 μmol/L, exceeding the 1 μmol/L target trough concentration in 67% of patients. No correlations between PG or PK and toxicity were observed.

conclusionsDespite alisertib activity in pediatric xenograft models and cogent pharmacokinetic-pharmacodynamic relationships in preclinical models and adults, the objective response rate in children and adolescents receiving single-agent alisertib was less than 5%.

Indexed as

AdolescentAnimalsAntineoplastic AgentsAzepinesBiomarkers, TumorChildChild, PreschoolDisease Models, AnimalDrug Resistance, NeoplasmFemaleHumansLeukemiaMaleMiceMultimodal ImagingNeoplasmsAntineoplastic AgentsAzepinesBiomarkers, TumorMLN 8237Protein Kinase InhibitorsPyrimidines

Identifiers

PMID30777875
PMCPMC6897379
OpenAlexW2915169245

What OpenQuestion holds

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Registered trials

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.