Evidence map›Paper›PMID 29223478›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2018

Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma.

Maeve A Lowery, David P Kelsen, Marinela Capanu, Sloane C Smith, Jonathan W Lee, Zsofia K Stadler, Malcolm J Moore, Hedy L Kindler, Talia Golan, Amiel Segal and 9 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2018. 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 96 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 3 pooled it
7.7field-weighted citation impact, top 2% 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.

NCT01585805 phase2active not recruitingnot on this map

A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma (Part II)

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2027Enrolled83ConditionsLocally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8ArmsBiopsy Procedure, Biospecimen Collection, Cisplatin, Computed Tomography, Gemcitabine
NCT02184195 phase3completednot on this map

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled154ConditionsGermline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the PancreasArmsOlaparib, Placebo
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 3 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. A Phase II Trial of Niraparib in Patients with Advanced Pancreatic Cancer Harboring Pathogenic Variants in ATM, BRCA1, BRCA2, PALB2, and CHEK2.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  6. Trial
  7. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a GermlineJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
  8. Article
  9. Review
  10. Review
  11. Review
  12. DNA Damage and Repair in Pancreatic Cancer-The Latest Findings.International journal of molecular sciences · 2025
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Frontiers in oncology · 2024
    Article

36 more citing papers are in PubMed but not listed here.

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

19 authors at 6 institutions in 3 countries.

Maeve A LoweryMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
David P KelsenMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Marinela CapanuMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Sloane C SmithMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Jonathan W LeeMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Zsofia K StadlerMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Malcolm J MoorePrincess Margaret Cancer Center- University Health Network, Toronto, Canada.
Hedy L KindlerUniversity of Chicago Medical Center, Chicago, IL, USA.
Talia GolanSheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Amiel SegalShare Zedek Medical Center, Jerusalem, Israel.
Hannah MaynardMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Ellen HollywoodMemorial Sloan Kettering Cancer Center, New York, NY, USA.
MaryEllen MoynahanMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Erin E Salo-MullenMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Richard Kinh Gian DoMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Alice P ChenNational Cancer Institute, Bethesda, MD, USA.
Kenneth H YuMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.
Laura H TangMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA. Electronic address: oreillye@mskcc.org.
Memorial Sloan Kettering Cancer Center · USNational Cancer Institute · USShaare Zedek Medical Center · ILTel Aviv University · ILUniversity Health Network · CAUniversity of Chicago Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Summer research experiences for medical students supervised by faculty mentorsR25CA020449 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Charlotte Eielson Ariyan · 1985 to 2026
$6.2M
NCI NIH HHS P30 CA008748NCI NIH HHS R25 CA020449
6 · The paper itself

Abstract

purposeBRCA-associated cancers have increased sensitivity to poly(ADP-ribose) polymerase inhibitors (PARPis). This single arm, non-randomised, multicentre phase II trial evaluated the response rate of veliparib in patients with previously treated BRCA1/2- or PALB2-mutant pancreatic adenocarcinoma (PDAC).

methodsPatients with stage III/IV PDAC and known germline BRCA1/2 or PALB2 mutation, 1-2 lines of treatment, Eastern Cooperative Oncology Group 0-2, were enrolled. Veliparib was dosed at a volume of 300 mg twice-daily (N = 3), then 400 mg twice-daily (N = 15) days 1-28. The primary end-point was to determine the response rate of veliparib; secondary end-points included progression-free survival (PFS), duration of response, overall survival (OS) and safety.

resultsSixteen patients were enrolled; male N = 8 (50%). Median age was 52 years (range 43-77). Five (31%) had a BRCA1 and 11 (69%) had a BRCA2 mutation. Fourteen (88%) patients had received prior platinum-based therapy. No confirmed partial responses (PRs) were seen: one (6%) unconfirmed PR was observed at 4 months with disease progression (PD) at 6 months; four (25%) had stable disease (SD), whereas 11 (69%) had PD as best response including one with clinical PD. Median PFS was 1.7 months (95% confidence interval [CI] 1.57-1.83) and median OS was 3.1 months (95% CI 1.9-4.1). Six (38%) patients had grade III toxicity, including fatigue (N = 3), haematology (N = 2) and nausea (N = 1).

conclusionsVeliparib was well tolerated, but no confirmed response was observed although four (25%) patients remained on study with SD for ≥ 4 months. Additional strategies in this population are needed, and ongoing trials are evaluating PARPis combined with chemotherapy (NCT01585805) and as a maintenance strategy (NCT02184195).

Indexed as

Genes, BRCA1Genes, BRCA2MutationAdenocarcinomaAdultAgedBenzimidazolesCarcinoma, Pancreatic DuctalFemaleHumansMaleMiddle AgedPancreatic NeoplasmsPoly(ADP-ribose) Polymerase InhibitorsProspective StudiesBenzimidazolesPoly(ADP-ribose) Polymerase InhibitorsveliparibBRCAGermlinePancreatic cancerPARP inhibitorPlatinumVeliparib

Identifiers

PMID29223478
PMCPMC7351022
OpenAlexW2775300375

What OpenQuestion holds

Textmetadata
LicenceTDM
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.