Evidence map›Paper›PMID 34435684›Full record

Trial reportJournal of clinical pharmacology2022

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies.

Xiaofei Zhou, Diane R Mould, Ying Yuan, Elizabeth Fox, Emily Greengard, Douglas V Faller, Karthik Venkatakrishnan

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.5field-weighted citation impact, top 38% 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
NCT02444884 phase1completednot on this map

A Phase I/II Study of MLN8237, an Oral Selective Small Molecule Inhibitor of Aurora A Kinase, in Children With Relapsed/Refractory Solid Tumors

TypeinterventionalSponsorChildren's Oncology GroupRan2008 to 2011Enrolled54ConditionsUnspecified Childhood Solid Tumor, Excluding CNS, NeuroblastomaArmsMLN8237
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
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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

7 authors at 5 institutions in 2 countries.

Xiaofei ZhouMillennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.ORCID 0000-0003-0319-1327
Diane R MouldProjections Research Inc, Phoenixville, Pennsylvania, USA.ORCID 0000-0002-8908-0136
Ying YuanMillennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Elizabeth FoxSt. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Emily GreengardUniversity of Minnesota, Minneapolis, Minnesota, USA.
Douglas V FallerMillennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Karthik VenkatakrishnanMillennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Takeda (United States) · USOno Pharmaceutical (United States) · USPhoenixville Hospital · USSt. Jude Children's Research Hospital · USUniversity of Minnesota · 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
Pediatric Phase 1/Pilot ConsortiumUM1CA097452 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI WEIGEL, BRENDA J. · 2009 to 2018
$17.7M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UM1 CA097452
6 · The paper itself

Abstract

Population pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in 2 clinical trials: NCT02444884 and NCT01154816. NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45 to 100 mg/m

Indexed as

AdolescentAntineoplastic AgentsAzepinesBody Surface AreaChildChild, PreschoolDrug Administration ScheduleFemaleHumansMaleMaximum Tolerated DoseModels, BiologicalNeoplasmsNeoplasm StagingProtein Kinase InhibitorsPyrimidinesAntineoplastic AgentsAzepinesMLN 8237Protein Kinase InhibitorsPyrimidinesalisertibAurora A kinaseexposure-safetypediatricpopulation pharmacokinetics

Identifiers

PMID34435684
PMCPMC9274904
OpenAlexW3193708103

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.