Evidence map›Paper›PMID 31347292›Full record

Trial reportCancer medicine2019

A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer.

Zishuo Ian Hu, Johanna C Bendell, Andrea Bullock, Noelle K LoConte, Hassan Hatoum, Paul Ritch, Hugo Hool, Joseph W Leach, James Sanchez, Davendra P S Sohal and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01647828 (A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer), which is not on this map. Cited by 59 papers.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed
3.9field-weighted citation impact, top 5% 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.

NCT01647828 phase1 / phase2completednot on this map

A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer

TypeinterventionalSponsorOncoMed Pharmaceuticals, Inc.Ran2012 to 2016Enrolled217ConditionsStage IV Pancreatic CancerArmsOMP-59R5, Gemcitabine, Placebo, Nab-Paclitaxel
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 80 citations in OpenAlex.

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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

22 authors at 16 institutions in 1 country.

Zishuo Ian HuMemorial Sloan Kettering Cancer Center, New York, New York.
Johanna C BendellSarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
Andrea BullockBeth Israel Deaconess Medical Center, Boston, Massachusetts.
Noelle K LoConteUniversity of Wisconsin, Cancer Center, Madison, Wisconsin.
Hassan HatoumUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Paul RitchFroedtert Hospital and Medical College of Wisconsin, Milwaukee, Wisconsin.
Hugo HoolTorrance Memorial Physician Network, Redondo Beach, California.
Joseph W LeachVirginia Piper Cancer Institute, Minneapolis, Minnesota.
James SanchezComprehensive Cancer Centers of Nevada, Henderson, Nevada.
Davendra P S SohalCleveland Clinic, Cleveland, Ohio.
John StricklerDuke University, Durham, North Carolina.
Ravindranath PatelComprehensive Blood and Cancer Center, Bakersfield, California.
Andrea Wang-GillamWashington University School of Medicine, Saint Louis, Missouri.
Irfan FirdausOncology Hematology Cancer, Inc., Cincinnati, Ohio.
Kenneth H YuMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-4774-2672
Ann M KapounOncomed Pharmaceuticals Inc, Redwood City, California.
Eric HolmgrenOncomed Pharmaceuticals Inc, Redwood City, California.
Lei ZhouOncomed Pharmaceuticals Inc, Redwood City, California.
Jakob DupontOncomed Pharmaceuticals Inc, Redwood City, California.
Vincent PicozziVirginia Mason Medical Center, Seattle, Washington.
Vaibhav SahaiUniversity of Michigan, Ann Arbor, Michigan.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-8076-9199
OncoMed (United States) · USMemorial Sloan Kettering Cancer Center · USBeth Israel Deaconess Medical Center · USCleveland Clinic · USComprehensive Blood & Cancer Center · USComprehensive Cancer Centers of Nevada · USDuke University · USFroedtert Hospital · USOncology Hematology Care · USSarah Cannon · USTorrance Memorial Medical Center · USUniversity of Michigan · USUniversity of Oklahoma Health Sciences Center · USUniversity of Wisconsin Carbone Cancer Center · USVirginia Mason Medical Center · USWashington University in St. Louis · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
National Cancer Institute Cancer Center Core P30-17 CA008748NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeNotch signaling dysregulation is implicated in the development of pancreatic adenocarcinoma (PDAC). Tarextumab is a fully human IgG2 antibody that inhibits Notch2/3 receptors. PATIENTS AND

methodsAphase 2, randomized, placebo-controlled, multicenter trial evaluated the activity of tarextumab in combination with nab-paclitaxel and gemcitabine in patients with metastatic PDAC. Patients were stratified based on ECOG performance score and Ca 19-9 level and randomized 1:1 to nab-paclitaxel, gemcitabine with either tarextumab or placebo. Based on preclinical and phase Ib results suggesting a positive correlation between Notch3 gene expression and tarextumab anti-tumor activity, patients were also divided into subgroups of low, intermediate, and high Notch3 gene expression. Primary endpoint was overall survival (OS) in all and in patients with the three Notch3 gene expression subgroups (≥25th, ≥50% and ≥75% percentiles); secondary end points included progression-free survival (PFS), 12-month OS, overall response rate (ORR), and safety and biomarker investigation.

resultsMedian OS was 6.4 months in the tarextumab group vs 7.9 months in the placebo group (HR = 1.34 [95% CI = 0.95, 1.89], P = .0985). No difference observed in OS in the Notch3 gene expression subgroups. PFS in the tarextumab-treated group (3.7 months) was significantly shorter compared with the placebo group (5.5 months) (hazard ratio was 1.43 [95% CI = 1.01, 2.01]; P = .04). Grade 3 diarrhea and thrombocytopenia were more common in the tarextumab group.

conclusionsThe addition of tarextumab to nab-paclitaxel and gemcitabine did not improve OS, PFS, or ORR in first-line metastatic PDAC, and PFS was specifically statistically worse in the tarextumab-treated patients. CLINICAL TRIAL REGISTRY NO: NCT01647828.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkersDeoxycytidineDisease ManagementFemaleGemcitabineHumansKaplan-Meier EstimateMaleMiddle AgedMolecular Targeted Therapy130-nm albumin-bound paclitaxelAlbuminsAntibodies, MonoclonalBiomarkersDeoxycytidineGemcitabinePaclitaxelReceptor, Notch2Receptor, Notch3tarextumabcancer stem cellgemcitabinenab-paclitaxelNotch 2/3 receptor inhibitorPancreatic cancertarextumab

Identifiers

PMID31347292
PMCPMC6718621
OpenAlexW2964555743

What OpenQuestion holds

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LicenceCC BY
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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.