Evidence map›Paper›PMID 34669023›Full record

ArticleCancer chemotherapy and pharmacology2022

A phase I study of veliparib with cyclophosphamide and veliparib combined with doxorubicin and cyclophosphamide in advanced malignancies.

Antoinette R Tan, Nancy Chan, Brian F Kiesel, Mark N Stein, Rebecca A Moss, Jyoti Malhotra, Joseph Aisner, Mansi Shah, Murugesan Gounder, Hongxia Lin and 6 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 45% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

16 authors at 4 institutions in 1 country.

Antoinette R TanRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA. Antoinette.Tan@atriumhealth.org.ORCID http://orcid.org/0000-0002-7895-7000
Nancy ChanRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Brian F KieselUniversity of Pittsburgh, Pittsburgh, PA, USA.
Mark N SteinRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Rebecca A MossRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Jyoti MalhotraRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Joseph AisnerRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Mansi ShahRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Murugesan GounderRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Hongxia LinRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Michael P KaneRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Yong LinRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Jiuping JiFrederick National Lab for Cancer Research, Bethesda, MD, USA.
Alice ChenDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Jan H BeumerUniversity of Pittsburgh, Pittsburgh, PA, USA.
Janice M MehnertRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Rutgers, The State University of New Jersey · USUniversity of Pittsburgh · USFrederick National Laboratory for Cancer Research · USNational Cancer Institute · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
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 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
PITT-CAL ETCTN PK Resource LaboratoryU24CA247643 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI TIMOTHY W SYNOLD, Raman Venkataramanan · 2020 to 2026
$3.6M
Cancer Pharmacokinetics Research SpecialistR50CA211241 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI PARISE, ROBERT · 2016 to 2025
$1.8M
Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis (U01)U01CA132194 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI DIPAOLA, ROBERT S. · 2008 to 2013
$1.6M
Dr. Salma Jabbour’s NCI Research Specialist (Clinician Scientist) Award (R50)R50CA275877 · NCI · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI Salma Jabbour · 2023 to 2026
$785k
NCI NIH HHS P30 CA047904NCI NIH HHS R50 CA211241NCI NIH HHS R50 CA275877NCI NIH HHS U01 CA099168NCI NIH HHS U01 CA132194NCI NIH HHS U24 CA247643NCI NIH HHS UM1 CA186690NCI NIH HHS UM1 CA186716
6 · The paper itself

Abstract

purposeVeliparib (V), an oral poly(ADP-ribose) polymerase (PARP) inhibitor, potentiates effects of alkylating agents and topoisomerase inhibitors in preclinical tumor models. We conducted a phase I trial of V with iv cyclophosphamide (C) and V plus iv doxorubicin (A) and C.

methodsObjectives were to establish the maximum tolerated dose (MTD) of the combinations, characterize V pharmacokinetics (PK) in the presence and absence of C, measure PAR in peripheral blood mononuclear cells (PBMCs) and γH2AX in circulating tumor cells (CTCs). In Group 1, dose escalations of V from 10 to 50 mg every 12 h Days 1-4 plus C 450 to 750 mg/m

resultsEighty patients were enrolled. MTD was not reached for V and C. MTD for V and AC was V 100 mg every 12 h Days 1-4 with AC (60/600 mg/m2) Day 3 every 21 days. V PK appears to be dose-dependent and has no effect on the PK of C. Overall, neutropenia and anemia were the most common adverse events. Objective response in V and AC treated groups was 22% (11/49). Overall clinical benefit rate was 31% (25/80). PAR decreased in PBMCs. Percentage of γH2AX-positive CTCs increased after treatment with V and AC.

conclusionV and AC can be safely combined. Activity was observed in patients with metastatic breast cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsCyclophosphamideDoxorubicinFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPoly Adenosine Diphosphate RibosePoly(ADP-ribose) Polymerase InhibitorsBenzimidazolesCyclophosphamideDoxorubicinPoly Adenosine Diphosphate RibosePoly(ADP-ribose) Polymerase InhibitorsveliparibPARP inhibitorsPharmacokineticsPhase I studyVeliparib

Identifiers

PMID34669023
PMCPMC8934569
OpenAlexW3207103941

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Registered trials

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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.