Evidence map›Paper›PMID 29338080›Full record

ArticleCancer2018

Phase 1 trial evaluating cisplatin, gemcitabine, and veliparib in 2 patient cohorts: Germline BRCA mutation carriers and wild-type BRCA pancreatic ductal adenocarcinoma.

Eileen M O'Reilly, Jonathan W Lee, Maeve A Lowery, Marinela Capanu, Zsofia K Stadler, Malcolm J Moore, Neesha Dhani, Hedy L Kindler, Hayley Estrella, Hannah Maynard and 11 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in 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 NCT01585805 (A Randomized Phase II Study of Gemcitabine, Cisplatin +/- Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/ PALB2 Mutation), which is not on this map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
6.4field-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
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. A Phase I/II Study of Veliparib (ABT-888) in Combination with 5-Fluorouracil and Oxaliplatin in Patients with Metastatic Pancreatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  3. 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
  4. DNA Damage and Repair in Pancreatic Cancer-The Latest Findings.International journal of molecular sciences · 2025
    Review
  5. Article
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  7. Article
  8. Review
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  11. Article
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  15. Review
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  19. Precision Medicine forCancers · 2022
    Review
  20. Review

2 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

21 authors at 6 institutions in 3 countries.

Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-8076-9199
Jonathan W LeeMemorial Sloan Kettering Cancer Center, New York, New York.
Maeve A LoweryMemorial Sloan Kettering Cancer Center, New York, New York.
Marinela CapanuMemorial Sloan Kettering Cancer Center, New York, New York.
Zsofia K StadlerMemorial Sloan Kettering Cancer Center, New York, New York.
Malcolm J MoorePrincess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Neesha DhaniPrincess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Hedy L KindlerUniversity of Chicago Medical Center, Chicago, Illinois.
Hayley EstrellaMemorial Sloan Kettering Cancer Center, New York, New York.
Hannah MaynardMemorial Sloan Kettering Cancer Center, New York, New York.
Talia GolanSheba Medical Center, Tel Hashomer, Israel.
Amiel SegalShare Zedek Medical Center, Jerusalem, Israel.
Erin E Salo-MullenMemorial Sloan Kettering Cancer Center, New York, New York.
Kenneth H YuMemorial Sloan Kettering Cancer Center, New York, New York.
Andrew S EpsteinMemorial Sloan Kettering Cancer Center, New York, New York.
Michal SegalMemorial Sloan Kettering Cancer Center, New York, New York.
Robin BrennerMemorial Sloan Kettering Cancer Center, New York, New York.
Richard K DoMemorial Sloan Kettering Cancer Center, New York, New York.
Alice P ChenNational Cancer Institute, Bethesda, Maryland.
Laura H TangMemorial Sloan Kettering Cancer Center, New York, New York.
David P KelsenMemorial Sloan Kettering Cancer Center, New York, New York.
Memorial Sloan Kettering Cancer Center · USUniversity Health Network · CANational Cancer Institute · USShaare Zedek Medical Center · ILTel Aviv University · ILUniversity 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

backgroundA phase 1 trial was used to evaluate a combination of cisplatin, gemcitabine, and escalating doses of veliparib in patients with untreated advanced pancreatic ductal adenocarcinoma (PDAC) in 2 cohorts: a germline BRCA1/2-mutated (BRCA+) cohort and a wild-type BRCA (BRCA-) cohort. The aims were to determine the safety, dose-limiting toxicities (DLTs), maximum tolerated dose, and recommended phase 2 dose (RP2D) of veliparib combined with cisplatin and gemcitabine and to assess the antitumor efficacy (Response Evaluation Criteria in Solid Tumors, version 1.1) and overall survival.

methodsGemcitabine and cisplatin were dosed at 600 and 25 mg/m

resultsSeventeen patients were enrolled: 9 BRCA+ patients, 7 BRCA- patients, and 1 patient with an unknown status. DLTs were reached at DL2A (80 mg twice daily on days 1 to 21). Two of the 5 patients in this cohort (40%) experienced grade 4 neutropenia and thrombocytopenia. Two grade 5 events occurred on protocol. The objective response rate in the BRCA+ cohort was 7 of 9 (77.8%). The median overall survival for BRCA+ patients was 23.3 months (95% confidence interval [CI], 3.8-30.2 months). The median overall survival for BRCA- patients was 11 months (95% CI, 1.5-12.1 months).

conclusionsThe RP2D of veliparib was 80 mg by mouth twice daily on days 1 to 12 in combination with cisplatin and gemcitabine; the DLT was myelosuppression. Substantial antitumor activity was seen in BRCA+ PDAC. A randomized phase 2 trial is currently evaluating cisplatin and gemcitabine with and without veliparib for BRCA+ PDAC (NCT01585805). Cancer 2018;124:1374-82. © 2018 American Cancer Society.

Indexed as

Germ-Line MutationAdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBRCA1 ProteinBRCA2 ProteinCarcinoma, Pancreatic DuctalCisplatinCohort StudiesDeoxycytidineFemaleFollow-Up StudiesGemcitabineHeterozygoteBenzimidazolesBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanCisplatinDeoxycytidineGemcitabineveliparibBRCAcisplatingermlinepancreatic cancerveliparib

Identifiers

PMID29338080
PMCPMC5867226
OpenAlexW2783439822

What OpenQuestion holds

Textmetadata
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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.