Evidence map›Paper›PMID 26171911›Full record

Trial reportGynecologic oncology2015

A phase II trial of trebananib (AMG 386; IND#111071), a selective angiopoietin 1/2 neutralizing peptibody, in patients with persistent/recurrent carcinoma of the endometrium: An NRG/Gynecologic Oncology Group trial.

Kathleen N Moore, Michael W Sill, Meaghan E Tenney, Christopher J Darus, David Griffin, Theresa L Werner, Peter G Rose, Robert Behrens

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

Trial report in Gynecologic oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.7field-weighted citation impact, top 9% 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

19 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
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  10. Immune-related geneTranslational cancer research · 2021
    Article
  11. Review
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  14. Article
  15. Article
  16. Review
  17. New therapies for advanced, recurrent, and metastatic endometrial cancers.Gynecologic oncology research and practice · 2017
    Review
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  19. 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

8 authors at 6 institutions in 1 country.

Kathleen N MooreStephenson Oklahoma Cancer Center, 800 NE 10th Street, Oklahoma City, OK 73104, United States. Electronic address: Kathleen-Moore@ouhsc.edu.
Michael W SillNRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263, United States. Electronic address: msill@gogstats.org.
Meaghan E TenneyUniversity of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, United States. Electronic address: mtenney@babies.bsd.uchicago.edu.
Christopher J DarusMaine Medical Center, 102 Campus Drive Unit 116, Scarborough, ME 04074, United States. Electronic address: darusc@mmc.org.
David GriffinUpstate Carolina CCOP Oncology Research, 101 East Wood Street, Spartanburg, SC 29303, United States. Electronic address: david_griffin@bshsi.org.
Theresa L WernerHuntsman Cancer Institute, University of Utah, 2000 Circle of Hope, Salt Lake City, UT 84112, United States. Electronic address: theresa.werner@hci.utah.edu.
Peter G RoseCleveland Clinic Foundation, 9500 Euclid Avenue, A81, Cleveland, OH 44106, United States. Electronic address: rosep@ccf.org.
Robert BehrensCancer Center of Iowa, Iowa Wide Oncology Research Coalition, 1221 Pleasant Street, Suite 450, Des Moines IA 50309, United States. Electronic address: rbehrens@cancercenterofiowa.com.
Cleveland Clinic · USIowa Oncology Research Association · USOklahoma State University Oklahoma City · USRoswell Park Comprehensive Cancer Center · USUniversity of Chicago · USUniversity of Utah · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
NCI NIH HHS 1 U10 CA180822NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

objectivesAng1 & 2 (angiopoietin-1; -2) interact with Tie2 receptors on endothelial cells to mediate vascular remodeling in an angiogenesis signaling pathway distinct from the VEGF axis. Trebananib is a peptide Fc fusion protein that binds Ang1 and 2 and prevents interaction with Tie2. The efficacy of trebananib in recurrent/persistent endometrial cancer (EC) was studied.

methodsThe primary objective was to determine the frequency of patients with objective tumor responses (ORR) and event-free survival for ≥6months (6-month EFS) and determine toxicity of trebananib at a dose and schedule of 15mg/kg, IV QW. Recurrent/persistent EC, measurable disease, and ≤2 prior chemotherapy lines were required.

resultsThirty-two patients were eligible and treated. The most common histologies were G1/2 endometrioid (31%), G3 endometrioid (28%) and serous (31.3%). 78% of patients had 1 prior regimen. Patients received 1-9+ cycles of trebananib; 24 patients (75%) received ≤2cycles. One patient had a partial response (3.1%); 8 patients had stable disease (25%) and 5 patients (15.6%) had 6 month EFS. Median progression-free survival and overall-survival were 1.97 months (90% CI 1.77-2.1) and 6.6 months (90% CI 4.01-14.75), respectively. Most common adverse events (AEs) were fatigue, anemia, and GI issues. Grade 3 and 4 AEs were: GI 31 and 0%; vascular 22 and 0%; metabolism/nutrition 19 and 3%; and general (including edema) 16 and 0%.

conclusionsTrebananib has insufficient single agent activity in recurrent EC to warrant further investigation at this dose/schedule.

Indexed as

AdultAgedAngiogenesis InhibitorsAngiopoietin-1Angiopoietin-2Endometrial NeoplasmsFemaleHumansMiddle AgedRecombinant Fusion ProteinsAngiogenesis InhibitorsAngiopoietin-1Angiopoietin-2ANGPT1 protein, humanANGPT2 protein, humanRecombinant Fusion ProteinstrebananibAngiogenesisEndometrial cancerNCT01210222Trebananib

Identifiers

PMID26171911
PMCPMC4692151
OpenAlexW2133936500

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.