Evidence map›Paper›PMID 21976672›Full record

Trial reportBlood2011

Phase 1/2 study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia.

Bob Löwenberg, Petra Muus, Gert Ossenkoppele, Philippe Rousselot, Jean-Yves Cahn, Norbert Ifrah, Giovanni Martinelli, Sergio Amadori, Ellin Berman, Pieter Sonneveld and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00497991 (A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.), which is not on this map. Cited by 70 papers.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed
–field-weighted citation impact
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.

NCT00497991 phase1completednot on this map

A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.

TypeinterventionalSponsorAstraZenecaRan2006 to 2010Enrolled65ConditionsMyeloid LeukemiaArmsAZD1152
3 · Its place in the literature

Who cites it

70 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Pandora's Box of AML: HowBiomedicines · 2025
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. The two sides of chromosomal instability: drivers and brakes in cancer.Signal transduction and targeted therapy · 2024
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Aurora B Inhibitors as Cancer Therapeutics.Molecules (Basel, Switzerland) · 2023
    Review

10 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

17 authors.

Bob LöwenbergDepartment of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands. b.lowenberg@erasmusmc.nl
Petra Muus
Gert Ossenkoppele
Philippe Rousselot
Jean-Yves Cahn
Norbert Ifrah
Giovanni Martinelli
Sergio Amadori
Ellin Berman
Pieter Sonneveld
Mojca Jongen-Lavrencic
Sophie Rigaudeau
Paul Stockman
Alison Goudie
Stefan Faderl
Elias Jabbour
Hagop Kantarjian

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

The primary objective of this 2-part phase 1/2 study was to determine the maximum-tolerated dose (MTD) of the potent and selective Aurora B kinase inhibitor barasertib (AZD1152) in patients with newly diagnosed or relapsed acute myeloid leukemia (AML). Part A determined the MTD of barasertib administered as a continuous 7-day infusion every 21 days. In part B, the efficacy of barasertib was evaluated at the MTD. In part A, 32 patients were treated with barasertib 50 mg (n = 3), 100 mg (n = 3), 200 mg (n = 3), 400 mg (n = 4), 800 mg (n = 7), 1200 mg (n = 6), and 1600 mg (n = 6). Dose-limiting toxicities (stomatitis/mucosal inflammation events) were reported in the 800 mg (n = 1), 1200 mg (n = 1), and 1600 mg (n = 2) groups. The MTD was defined as 1200 mg. In part B, 32 patients received barasertib 1200 mg. In each part of the study, 8 of 32 patients had a hematologic response according to Cheson AML criteria. The most commonly reported grade ≥ 3 events were febrile neutropenia (n = 24) and stomatitis/mucosal inflammation (n = 16). We concluded that the MTD of barasertib is 1200 mg in patients with relapsed or newly diagnosed AML. Toxicity was manageable and barasertib treatment resulted in an overall hematologic response rate of 25%. This study is registered at www.ClinicalTrials.gov as NCT00497991.

Indexed as

OrganophosphatesProtein Kinase InhibitorsQuinazolinesAgedAged, 80 and overAurora Kinase BAurora KinasesDose-Response Relationship, DrugFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedProtein Serine-Threonine KinasesRecurrenceSeverity of Illness Index2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphateAURKB protein, humanAurora Kinase BAurora KinasesOrganophosphatesProtein Kinase InhibitorsProtein Serine-Threonine KinasesQuinazolines

Identifiers

PMID21976672
PMCPMC4186639

What OpenQuestion holds

Textmetadata
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.