Evidence map›Paper›PMID 30041929›Full record

Trial reportGynecologic oncology2018

Phase II evaluation of dalantercept in the treatment of persistent or recurrent epithelial ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study.

Robert A Burger, Wei Deng, Vicky Makker, Yvonne Collins, Heidi Gray, Robert Debernardo, Lainie P Martin, Carol Aghajanian

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. BMP9 regulates the endothelial secretome to drive pulmonary hypertension.bioRxiv : the preprint server for biology · 2025
    Article
  5. Article
  6. Review
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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

8 authors.

Robert A BurgerDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA 19104, United States of America. Electronic address: robert.burger@uphs.upenn.edu.
Wei DengNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY 14263, United States of America. Electronic address: wdeng@gogstats.org.
Vicky MakkerDepartment of Medicine, Memorial Sloan Kettering Cancer, New York, NY 10065, United States of America. Electronic address: makkerv@mskcc.org.
Yvonne CollinsDepartment of Obstetrics & Gynecology, University of Illinois at Chicago CCOP, Chicago, IL 60612, United States of America. Electronic address: yvonne.collins-md@advocatehealth.com.
Heidi GrayDept. of OB/GYN, Washington University School of Medicine, Seattle, WA 98195, United States of America. Electronic address: hgray@u.washington.edu.
Robert DebernardoDepartment of Obstetrics & Gynecology, Case Western University Hospital, Cleveland, OH 44106, United States of America. Electronic address: debernr@ccf.org.
Lainie P MartinDepartment of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, United States of America. Electronic address: lainie.martin@fccc.edu.
Carol AghajanianDepartment of Medicine, Memorial Sloan Kettering Cancer, New York, NY 10065, United States of America. Electronic address: aghajanc@MSKCC.ORG.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 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, 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
OB/GYN FACULTY RESEARCH CAREER DEVELOPMENT PROGRAMK12HD001258 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI JENKINS, TODD R · 1999 to 2019
$5.6M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NICHD NIH HHS K12 HD001258
6 · The paper itself

Abstract

objectiveTo determine the efficacy of dalantercept, a soluble ALK1 inhibitor receptor fusion protein, in patients with persistent or recurrent ovarian carcinoma and related malignancies.

methodsEligibility criteria included measurable disease, 1-2 prior cytotoxic regimens and GOG performance status (PS) ≤2. Dalantercept was administered subcutaneously at 1.2 mg/kg every 3 weeks until disease progression or development of unacceptable toxicity. The primary null hypothesis was the probability of response ≤0.10 and the probability of 6-month progression-free survival without receipt of non-protocol therapy (event-free survival at 6 months, EFS6) ≤0.15, using RECIST 1.1 criteria.

resultsThe first stage was closed after enrollment of 30 participants with median age of 56.5 years, high-grade serous histology in 76.7%, 2 prior regimens in 46.7%, and platinum-free interval <6 months in 73.3%. All participants discontinued dalantercept, 24 (80.0%), 5 (16.7%) and 1 (3.3%) due to progression, toxicity, and other reason, respectively. The median number of treatment cycles per patient was 2 (range 1-29). There were six treatment-related grade 3 AEs and no grade ≥4 AEs. There were no objective responses. EFS6 was reached in 20% (6 out of 30 participants, 90% CI 9.1% to 35.7%).

conclusionsThough safe, dalantercept as administered had limited efficacy in this patient population overall.

Indexed as

Activin Receptors, Type IIAdultAgedAntineoplastic AgentsCarcinomaDisease-Free SurvivalDisease ProgressionFallopian Tube NeoplasmsFemaleHumansImmunoglobulin Fc FragmentsMiddle AgedNeoplasm Recurrence, LocalNeoplasm, ResidualOvarian NeoplasmsPeritoneal NeoplasmsActivin Receptors, Type IIALK1-Fc fusion protein, humanAntineoplastic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsClinical trialDalanterceptOvarian cancerPhase II

Identifiers

PMID30041929
PMCPMC6546175

What OpenQuestion holds

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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.