Evidence map›Paper›PMID 30456480›Full record

ArticleCancer chemotherapy and pharmacology2019

Population pharmacokinetics and exposure-response assessment of veliparib co-administered with temozolomide in patients with myeloid leukemias.

Renu Singh, Shailly Mehrotra, Mathangi Gopalakrishnan, Ivana Gojo, Judith E Karp, Jacqueline M Greer, Alice Chen, Richard Piekarz, Brian F Kiesel, Jogarao Gobburu and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
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 4 institutions in 1 country.

Renu SinghCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
Shailly MehrotraCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
Mathangi GopalakrishnanCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA. mgopalakrishnan@rx.umaryland.edu.ORCID 0000-0003-2881-9870
Ivana GojoThe Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Judith E KarpThe Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Jacqueline M GreerThe Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Alice ChenInvestigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Richard PiekarzInvestigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Brian F KieselUPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Jogarao GobburuCenter for Translational Medicine, University of Maryland, Baltimore, MD, USA.
Michelle A RudekThe Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Jan H BeumerUPMC Hillman Cancer Center, Pittsburgh, PA, USA. beumerj@gmail.com.
ETCTN-6745 study team
University of Maryland, Baltimore · USUPMC Hillman Cancer Center · USNational Cancer Institute · USSidney Kimmel Comprehensive Cancer Center · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
NCI ET-CTN with Phase i Emphasis at UPCIUM1CA186690 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD, Farshid Dayyani · 2014 to 2026
$9.1M
PHASE I TRIALS OF ANTICANCER AGENTSU01CA070095 · NCI · JOHNS HOPKINS UNIVERSITY · PI CARDUCCI, MICHAEL A · 1995 to 2013
$8.6M
Phase I Clinical Trials of Novel Anticancer AgentsU01CA099168 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CHU, EDWARD · 2003 to 2013
$5.0M
Wisconsin and New Jersey Alliance in Precision Experimental TherapeuticsUM1CA186716 · NCI · RBHS -CANCER INSTITUTE OF NEW JERSEY · PI JABBOUR, SALMA, LIU, GLENN · 2014 to 2019
$4.1M
Cancer Pharmacokinetics Research SpecialistR50CA211241 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI PARISE, ROBERT · 2016 to 2025
$1.8M
NCATS NIH HHS UL1 TR001079NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA047904NCI NIH HHS R50 CA211241NCI NIH HHS U01 CA070095NCI NIH HHS U01 CA099168NCI NIH HHS UM1 CA186690NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186716
6 · The paper itself

Abstract

purposeVeliparib is an oral inhibitor of poly(ADP-ribose) polymerase enzyme. Combination of veliparib and temozolomide was well-tolerated and demonstrated clinical activity in older patients with relapsed or refractory acute myeloid leukemia (AML) or AML arising from pre-existing myeloid malignancies. We aimed to perform quantitative assessments of pharmacokinetics, efficacy, and safety of veliparib in this patient population to inform future trial design.

methodsPopulation pharmacokinetic analysis was performed using Phoenix

resultsA two-compartment model with first-order elimination and a first-order absorption with lag-time adequately described veliparib pharmacokinetics. CL

conclusionsVeliparib with temozolomide presents a promising combination for older patients with myeloid leukemias. An exposure-safety relationship was established for this combination. Further clinical investigations aimed at elucidating the veliparib exposure-efficacy/safety relationship and optimizing dosing recommendations for maximizing benefit-risk in patients with advanced myeloid malignancies should study veliparib doses ranging up to 120 mg in combination with temozolomide.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesDrug Therapy, CombinationFemaleFollow-Up StudiesHumansIncidenceLeukemia, Myeloid, AcuteMaleMarylandMiddle AgedModels, StatisticalAntineoplastic Agents, AlkylatingBenzimidazolesPoly(ADP-ribose) Polymerase InhibitorsTemozolomideveliparibExposure-responsePharmacometricsTemozolomideVeliparib

Identifiers

PMID30456480
PMCPMC6404524
OpenAlexW2901175244

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.