Evidence map›Paper›PMID 28419486›Full record

Trial reportJournal of clinical pharmacology2017

Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range.

Michael J Hanley, Diane R Mould, Timothy J Taylor, Neeraj Gupta, Kaveri Suryanarayan, Rachel Neuwirth, Dixie-Lee Esseltine, Terzah M Horton, Richard Aplenc, Todd A Alonzo and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2017. 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 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT00873093 phase2completednot on this map

A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2009 to 2014Enrolled148ConditionsB-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic LymphomaArmsL-asparaginase, doxorubicin hydrochloride, therapeutic hydrocortisone, vincristine sulfate, cytarabine
NCT01371981 phase3completednot on this map

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2011 to 2026Enrolled1,645ConditionsAcute Myeloid Leukemia, Leukemia Cutis, Myeloid Neoplasm, Myeloid SarcomaArmsAsparaginase, Bortezomib, Cytarabine, Daunorubicin Hydrochloride, Etoposide
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Actinomycin D and bortezomib disrupt protein homeostasis in Wilms tumor.bioRxiv : the preprint server for biology · 2024
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
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

13 authors at 8 institutions in 2 countries.

Michael J HanleyMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Diane R MouldProjections Research Inc, Phoenixville, PA, USA.
Timothy J TaylorProjections Research Inc, Phoenixville, PA, USA.
Neeraj GuptaMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Kaveri SuryanarayanMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Rachel NeuwirthMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Dixie-Lee EsseltineMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Terzah M HortonBaylor College of Medicine, Dan L. Duncan Cancer Center and Texas Children's Cancer and Hematology Centers, Texas Children's Hospital, Houston, TX, USA.
Richard AplencChildren's Hospital of Philadelphia, Philadelphia, PA, USA.
Todd A AlonzoUniversity of Southern California, Los Angeles, CA, USA.
Xiaomin LuUniversity of Florida, Gainesville, FL, USA.
Ashley MiltonMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Karthik VenkatakrishnanMillennium Pharmaceuticals Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Takeda (Japan) · JPMillennium Engineering and Integration (United States) · USPhoenixville Hospital · USTakeda (United States) · USBaylor College of Medicine · USChildren's Hospital of Philadelphia · USUniversity of Florida · USUniversity of Southern California · US

Funding

COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Identifying Cell Stress Proteins that Predict Clinical Response in Pediatric AMLR01CA164024 · NCI · BAYLOR COLLEGE OF MEDICINE · PI HORTON, TERZAH M · 2013 to 2017
$1.7M
Proteosome Inhibition Therapy for Hematologic MalignancyK23CA113775 · NCI · BAYLOR COLLEGE OF MEDICINE · PI HORTON, TERZAH M · 2006 to 2010
$670k
NCI NIH HHS K23 CA113775NCI NIH HHS R01 CA164024NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

This population analysis described the pharmacokinetics of bortezomib after twice-weekly, repeat-dose, intravenous administration in pediatric patients participating in 2 clinical trials: the phase 2 AALL07P1 (NCT00873093) trial in relapsed acute lymphoblastic leukemia and the phase 3 AAML1031 (NCT01371981) trial in de novo acute myelogenous leukemia. The sources of variability in the pharmacokinetic parameters were characterized and quantified to support dosing recommendations. Patients received intravenous bortezomib 1.3 mg/m

Indexed as

Models, BiologicalAdolescentAntineoplastic AgentsBody Surface AreaBortezomibChildChild, PreschoolHumansLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaAntineoplastic AgentsBortezomibbortezomibleukemiamultiple myelomapediatric pharmacokineticspopulation pharmacokineticsproteasome inhibitor

Identifiers

PMID28419486
PMCPMC5561493
OpenAlexW2605802780

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.