Evidence map›Paper›PMID 29527010›Full record

ArticleBritish journal of cancer2018

A phase 1 dose-escalation study of veliparib with bimonthly FOLFIRI in patients with advanced solid tumours.

Jordan Berlin, Ramesh K Ramanathan, John H Strickler, Deepa S Subramaniam, John Marshall, Yoon-Koo Kang, Robert Hetman, Matthew W Dudley, Jiewei Zeng, Caroline Nickner and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01123876 (A Phase 1 Open-Label, Dose-Escalation Study of Veliparib in Combination With Bimonthly FOLFIRI in Subjects With Advanced Solid Tumors), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.4field-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.

NCT01123876 phase1completednot on this map

A Phase 1 Open-Label, Dose-Escalation Study of Veliparib in Combination With Bimonthly FOLFIRI in Subjects With Advanced Solid Tumors

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2010 to 2015Enrolled60ConditionsGastric CancerArmsVeliparib
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Review
  3. PARP Inhibitors in Colorectal Malignancies: A 2023 Update.Reviews on recent clinical trials · 2024
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. PARP inhibitors in gastric cancer: beacon of hope.Journal of experimental & clinical cancer research : CR · 2021
    Review
  17. Review
  18. Precision medicine in gastric cancer.World journal of gastrointestinal oncology · 2019
    Review
  19. Review
  20. 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

15 authors at 9 institutions in 2 countries.

Jordan BerlinVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Ramesh K RamanathanTranslational Genomics Research Institute - Virginia G. Piper Cancer Center, Scottsdale, AZ, USA.
John H StricklerDuke University Medical Center, Durham, NC, USA.
Deepa S SubramaniamLombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
John MarshallLombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Yoon-Koo KangAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Robert HetmanAbbVie Inc, North Chicago, IL, USA.
Matthew W DudleyAbbVie Inc, North Chicago, IL, USA.
Jiewei ZengAbbVie Inc, North Chicago, IL, USA.
Caroline NicknerAbbVie Inc, North Chicago, IL, USA.
Hao XiongAbbVie Inc, North Chicago, IL, USA.
Philip KomarnitskyAbbVie Inc, North Chicago, IL, USA.
Stacie Peacock ShepherdAbbVie Inc, North Chicago, IL, USA.
Herbert HurwitzDuke University Medical Center, Durham, NC, USA.
Heinz-Josef LenzDivision of Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. LENZ@med.usc.edu.
AbbVie (United States) · USDuke Medical Center · USCorcept Therapeutics (United States) · USGeorgetown University · USGeorgetown University Medical Center · USTranslational Genomics Research Institute · USUlsan College · KRUniversity of Southern California · USVanderbilt-Ingram Cancer Center

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVeliparib is a potent poly(ADP-ribose) polymerase inhibitor. This phase 1 study aimed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of veliparib combined with various FOLFIRI regimens in patients with solid tumours.

methodsPatients received veliparib (10-270 mg BID, days 1-5, 15-19) and FOLFIRI (days 1-3, 15-17) in three regimens containing 5-fluorouracil 2,400 mg/m

resultsNinety-two patients received ≥1 veliparib dose. MTD was not reached; RP2D was set at 200 mg BID veliparib plus FOLFIRI (without 5-fluorouracil bolus). Most common treatment-emergent adverse events were neutropenia (66.3%), diarrhoea, and nausea (60.9% each). Dose-limiting toxicities (n = 4) were grade 3 gastritis and grade 4 neutropenia and febrile neutropenia. Veliparib exposure was dose-proportional, with no effects on the pharmacokinetics of FOLFIRI components. Fifteen patients had a partial response (objective response rate, 17.6%).

conclusionsThe acceptable safety profile and preliminary antitumour activity of veliparib plus FOLFIRI support further evaluation of this combination.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesCamptothecinDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasmsTreatment OutcomeBenzimidazolesCamptothecinFluorouracilLeucovorinveliparib

Identifiers

PMID29527010
PMCPMC5933261
OpenAlexW2789896032

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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.