Evidence map›Paper›PMID 36853577›Full record

ArticleBreast cancer research and treatment2023

A phase 1 study of veliparib (ABT-888) plus weekly carboplatin and paclitaxel in advanced solid malignancies, with an expansion cohort in triple negative breast cancer (TNBC) (ETCTN 8620).

Monica K Malhotra, Shalu Pahuja, Brian F Kiesel, Leonard J Appleman, Fei Ding, Yan Lin, Hussein A Tawbi, Ronald G Stoller, James J Lee, Chandra P Belani and 8 more

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

Article in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 21% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. 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

18 authors at 6 institutions in 1 country.

Monica K MalhotraDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Shalu Pahuja *Division of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Brian F KieselCancer Therapeutics Program, UPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Leonard J ApplemanDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Fei DingBiostatistics Facility, UPMC Hillman Cancer Center, Pittsburgh, PA, USA.
Yan LinDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.
Hussein A TawbiDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Ronald G StollerDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
James J LeeDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Chandra P BelaniPenn State Cancer Institute, Penn State College of Medicine, Hershey, PA, USA.
Alice P ChenDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, USA.
Vincent L GirandaAbbVie Laboratories, North Chicago, IL, USA.
Stacie Peacock ShepherdAbbVie Laboratories, North Chicago, IL, USA.
Leisha A EmensDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
S Percy IvyInvestigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
Edward ChuDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Jan H BeumerDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. beumerj@gmail.com.ORCID http://orcid.org/0000-0002-8978-9401
Shannon PuhallaDivision of Hematology/Oncology, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. puhallasl@upmc.edu.
University of Pittsburgh · USAbbVie (United States) · USNational Cancer Institute · USMontefiore Medical Center · USPenn State Milton S. Hershey Medical Center · USUPMC Hillman Cancer Center · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2016 to 2025
$129.3M
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
PITT-CAL ETCTN PK Resource LaboratoryU24CA247643 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI TIMOTHY W SYNOLD, Raman Venkataramanan · 2020 to 2026
$3.6M
NCATS NIH HHS UL1 TR001857NCI NIH HHS P30 CA047904NCI NIH HHS P30CA047904NCI NIH HHS U01 CA099168NCI NIH HHS U01CA099168NCI NIH HHS U24 CA247643NCI NIH HHS U24CA247643NCI NIH HHS UM1 CA186690NCI NIH HHS UM1CA186690
6 · The paper itself

Abstract

backgroundVeliparib is a poly-ADP-ribose polymerase (PARP) inhibitor, and it has clinical activity with every 3 weeks carboplatin and paclitaxel. In breast cancer, weekly paclitaxel is associated with improved overall survival. We aimed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of veliparib with weekly carboplatin and paclitaxel as well as safety, pharmacokinetics, and preliminary clinical activity in triple negative breast cancer (TNBC).

methodsPatients with locally advanced/metastatic solid tumors and adequate organ function were eligible. A standard 3 + 3 dose-escalation design was followed by a TNBC expansion cohort. Veliparib doses ranging from 50 to 200 mg orally bid were tested with carboplatin (AUC 2) and paclitaxel (80 mg/m

resultsThirty patients were enrolled, of whom 22 had TNBC. Two dose-limiting toxicities were observed. The RP2D was determined to be 150 mg PO bid veliparib with weekly carboplatin and paclitaxel 2 weeks on, 1 week off, based on hematologic toxicity requiring dose reduction in the first 5 cycles of treatment. The most common grade 3/4 AEs included neutropenia, anemia, and thrombocytopenia. PK parameters of veliparib were comparable to single-agent veliparib. In 23 patients with evaluable disease, the ORR was 65%. In 19 patients with TNBC with evaluable disease, the ORR was 63%.

conclusionVeliparib can be safely combined with weekly paclitaxel and carboplatin, and this triplet combination has promising clinical activity.

Indexed as

AnemiaBreast NeoplasmsTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCarboplatinFemaleHumansPaclitaxelBenzimidazolesCarboplatinPaclitaxelveliparibDNA damagePARPPharmacokineticsPhase 1 studySolid tumorsTriple negative breast cancerVeliparib

Identifiers

PMID36853577
PMCPMC10710035
OpenAlexW4322617704

What OpenQuestion holds

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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.