Trial reportGynecologic oncology2014
A phase II evaluation of nintedanib (BIBF-1120) in the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study.
Trial report in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it, 88 citations in OpenAlex.
- ESGO/ESTRO/ESP Guidelines for the management of patients with endometrial carcinoma.Virchows Archiv : an international journal of pathology · 2021Guideline
- Phase II Study of Erdafitinib in Patients With Tumors With Fibroblast Growth Factor Receptor Mutations or Fusions: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K2.JCO precision oncology · 2024Trial
- Phase II Trial of Cabozantinib in Recurrent/Metastatic Endometrial Cancer: A Study of the Princess Margaret, Chicago, and California Consortia (NCI9322/PHL86).Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Trial
- A phase II evaluation of brivanib in the treatment of persistent or recurrent carcinoma of the cervix: An NRG Oncology/Gynecologic Oncology Group study.Gynecologic oncology · 2017Trial
- 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.Gynecologic oncology · 2015Trial
- Review
- Cediranib with weekly paclitaxel or olaparib versus weekly paclitaxel for advanced or recurrent endometrial cancer (COPELIA): a multicentre, open-label, randomised, phase 2 trial in the UK.EClinicalMedicine · 2026Article
- A New Type of Endometrial Cancer Models in Mice Revealing the Functional Roles of Genetic Drivers and Exploring their Susceptibilities.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
- Combat Against Gynecological Cancers with Blood Vessels as Entry Point: Anti-Angiogenic Drugs, Clinical Trials and Pre-Clinical Nano-Delivery Platforms.International journal of nanomedicine · 2023Review
- Review
- Review
- Review
- Advantages of Tyrosine Kinase Anti-Angiogenic Cediranib over Bevacizumab: Cell Cycle Abrogation and Synergy with Chemotherapy.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Inhibition of FGF-FGFR and VEGF-VEGFR signalling in cancer treatment.Cell proliferation · 2021Review
- A clear cancer cell line (150057) derived from human endometrial carcinoma harbors two novel mutations.BMC cancer · 2020Article
- Small-Molecule Inhibitors (SMIs) as an Effective Therapeutic Strategy for Endometrial Cancer.Cancers · 2020Review
- Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.Signal transduction and targeted therapy · 2020Review
- Estimation of Percentage of Patients With Fibroblast Growth Factor Receptor Alterations Eligible for Off-label Use of Erdafitinib.JAMA network open · 2019Article
- Deciphering role of FGFR signalling pathway in pancreatic cancer.Cell proliferation · 2019Review
- Clinical trials in gynecologic oncology: Past, present, and future.Gynecologic oncology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 8 institutions in 1 country.
Funding
Abstract
introductionPatients presenting with advanced, recurrent, or metastatic endometrial cancer have limited treatment options. On behalf of the Gynecologic Oncology Group, we conducted this phase II trial of nintedanib (BIBF 1120), a potent small molecule triple receptor tyrosine kinase inhibitor of PDGFR α and β, FGFR 1/3, and VEGFR 1-3, in this population.
objectivesThe primary objectives were to estimate event-free survival (EFS) at 6 months and the proportion of patients who have an objective tumor response. In addition, we sought to determine the nature and degree of toxicity. Secondary objectives were to estimate progression-free and overall survival.
methodsThis was a two-stage, single-arm phase II study. Eligible patients were treated with single-agent nintedanib at a dose of 200mg twice daily.
resultsOf 37 patients enrolled, 32 were eligible. There were zero complete and three partial responses for an overall response rate of 9.4% (90% 2-sided CI=2.6-22.5%). Seven patients (21.9%; 90% 2-sided CI=10.7-37.2%) were EFS at 6 months, with one patient continuing on study at the time of this writing. Serious toxicity included the following grade 3 events: gastrointestinal toxicity (5), neutropenia (1), edema (1), hypertension (1), and liver function abnormalities (5).
conclusionsNintedanib lacked sufficient activity as a single agent to warrant enrollment to second stage. However, preclinical data indicate it may be synergistic with paclitaxel in a population of patients enriched for specific p53 mutations that result in loss of function. Subsequent studies may evaluate this agent in combination with paclitaxel.
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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.