Evidence map›Paper›PMID 25888978›Full record

Trial reportGynecologic oncology2015

Phase II evaluation of dalantercept, a soluble recombinant activin receptor-like kinase 1 (ALK1) receptor fusion protein, for the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study 0229N.

Vicky Makker, Virginia L Filiaci, Lee-May Chen, Christopher J Darus, James E Kendrick, Gregory Sutton, Katherine Moxley, Carol Aghajanian

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 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
8.5field-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.

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

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. ALK1 signaling in development and disease: new paradigms.Cellular and molecular life sciences : CMLS · 2017
    Review
  14. Role of bone morphogenetic proteins in sprouting angiogenesis: differential BMP receptor-dependent signaling pathways balance stalkFASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2017
    Article
  15. New therapies for advanced, recurrent, and metastatic endometrial cancers.Gynecologic oncology research and practice · 2017
    Review
  16. Article
  17. Article
  18. Catching a Disease: A Molecular Trap as a Therapy for Pulmonary Arterial Hypertension.American journal of respiratory and critical care medicine · 2016
    Article
  19. Review
  20. Article
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 7 institutions in 1 country.

Vicky MakkerMedical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States. Electronic address: makkerv@mskcc.org.
Virginia L FiliaciNRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States.
Lee-May ChenObstetrics and Gynecology, University of California, San Francisco, San Francisco, CA 94115, United States.
Christopher J DarusGynecologic Oncology, Maine Medical Center, Scarborough, ME 04074, United States.
James E KendrickGynecologic Oncology, Florida Hospital Cancer Institute Orlando, FL 32804, United States.
Gregory SuttonGynecologic Oncology, St. Vincent Hospitals and Health Services, Indianapolis, IN 46269, United States.
Katherine MoxleyObstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, United States.
Carol AghajanianMedical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, United States.
Florida Hospital Cancer Institute · USMaine Medical Center · USMemorial Sloan Kettering Cancer Center · USRoswell Park Comprehensive Cancer Center · USSt. Vincent Hospital · USUniversity of California, San Francisco · USUniversity of Oklahoma Health Sciences Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
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 · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
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
Network Lead Academic Participating Site: Memorial Sloan-Kettering Cancer CenterU10CA180791 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI AGHAJANIAN, CAROL, MORRIS, MICHAEL J · 2014 to 2018
$4.6M
NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

objectiveThis two-stage phase II study assessed activity of single agent dalantercept in patients with recurrent/persistent endometrial carcinoma (EMC).

methodsEligible patients had persistent/recurrent EMC after 1-2 prior cytotoxic regimens, measurable disease (RECIST 1.1), and GOG performance≤2. Dalantercept 1.2mg/kg subcutaneous was administered once every 3weeks until disease progression (PD)/development of prohibitory toxicity. Primary objectives were to estimate the proportion of patients with persistent/recurrent EMC, who survive progression-free without receiving non-protocol therapy (TPFS) for at least 6months and to estimate the proportion having objective tumor response.

resultsAll 28 enrolled patients were eligible and evaluable. Median age: 62years. Most common histologies: 32% Grade 1/2 endometrioid and 54% serous tumors. Prior treatment: 1 or 2 regimens in 82% and 18% of patients, respectively. Eighteen patients received prior radiation therapy. Patients received 1-12 cycles of dalantercept, and 46% of patients received ≤2cycles. The most common adverse events (AE) were fatigue, anemia, constipation and peripheral edema. Grade 3/4 AEs occurred in 39% and 4% of patients. One grade 5 gastric hemorrhage in a patient with a history of radiation fibrosis/small bowel obstruction was deemed possibly dalantercept-related. All patients are off study: 86% for PD. No ORs were observed; 57% had stable disease and 11% had TPFS>6 mos. Median progression-free and overall survival: 2.1months (90% CI: 1.4-3.2) and 14.5months (90% CI: 7.0-17.5), respectively.

conclusionsDalantercept has insufficient single agent activity in recurrent EMC to warrant further investigation at this dose level and schedule.

Indexed as

Activin Receptors, Type IIAdultAgedDisease-Free SurvivalEndometrial NeoplasmsFemaleHumansImmunoglobulin Fc FragmentsMiddle AgedNeoplasm Recurrence, LocalNeovascularization, PathologicRecombinant Fusion ProteinsActivin Receptors, Type IIALK1-Fc fusion protein, humanImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsALK-1DalanterceptRecurrent endometrial cancer

Identifiers

PMID25888978
PMCPMC4615687
OpenAlexW2139486407

What OpenQuestion holds

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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.