Evidence map›Paper›PMID 25338318›Full record

Trial reportJournal of neuro-oncology2015

Phase II trial of triple tyrosine kinase receptor inhibitor nintedanib in recurrent high-grade gliomas.

Andrew D Norden, David Schiff, Manmeet S Ahluwalia, Glenn J Lesser, Lakshmi Nayak, Eudocia Q Lee, Mikael L Rinne, Alona Muzikansky, Jorg Dietrich, Benjamin Purow and 11 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01380782 (Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas), which is not on this map. Cited by 42 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 4 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT01380782 phase2completednot on this map

Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas

TypeinterventionalSponsorPatrick Y. Wen, MDRan2012 to 2014Enrolled37ConditionsGlioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic OligodendrogliomaArmsBIBF 1120
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 4 syntheses or guidelines pooled it, 60 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

21 authors at 9 institutions in 1 country.

Andrew D NordenDivision of Neuro-Oncology, Department of Neurology, Brigham and Women's Hospital, 75 Francis St., Boston, MA, 02115, USA, anorden@partners.org.
David Schiff
Manmeet S Ahluwalia
Glenn J Lesser
Lakshmi Nayak
Eudocia Q Lee
Mikael L Rinne
Alona Muzikansky
Jorg Dietrich
Benjamin Purow
Lisa M Doherty
Debra C LaFrankie
Julee R Pulverenti
Jennifer A Rifenburg
Sandra F Ruland
Katrina H Smith
Sarah C Gaffey
Christine McCluskey
Keith L Ligon
David A Reardon
Patrick Y Wen
Dana-Farber Cancer Institute · USCenter for Neuro-Oncology · USBrigham and Women's Hospital · USLemuel Shattuck Hospital · USUniversity of Virginia · USCleveland Clinic · USHarvard University · USMassachusetts General Hospital · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bevacizumab is FDA-approved for patients with recurrent GBM. However, the median duration of response is only 4 months. Potential mechanisms of resistance include upregulated FGF signaling and increased PDGF-mediated pericyte coverage. Nintedanib is an oral, small-molecule tyrosine kinase inhibitor of PDGFR α/β, FGFR 1-3, and VEGFR 1-3 that may overcome resistance to anti-VEGF therapy. This was a two-stage phase II trial in adults with first or second recurrence of GBM, stratified by prior bevacizumab therapy (ClinicalTrials.gov number NCT01380782; 1199.94). The primary endpoint was PFS6 in the bevacizumab-naive arm (Arm A) and PFS3 in the post-bevacizumab arm (Arm B). Up to 10 anaplastic glioma (AG) patients were accrued to each arm in exploratory cohorts. Twenty-two patients enrolled in Arm A and 14 in Arm B. Arm A included 12 GBMs (55 %), 13 patients with one prior regimen (59 %), and median age 54 years (range 28-75). Arm B included 10 GBMs (71 %), one patient with one prior regimen (7 %), and median age 52 years (range 32-70). Median KPS overall was 90 (range 60-100). There were no responses. In Arm A (GBM only), PFS6 was 0 %, median PFS 28 days (95 % CI 27-83), and median OS 6.9 months (3.7-8.1). In Arm B (GBM only), PFS3 was 0 %, median PFS 28 days (22-28), and median OS 2.6 months (1.0-6.9). Among AG patients in each arm, PFS6 was 0 %. Treatment was well tolerated. In conclusion, nintedanib is not active against recurrent high-grade glioma, regardless of prior bevacizumab therapy.

Indexed as

AdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCohort StudiesFemaleGliomaHumansIndolesKaplan-Meier EstimateKarnofsky Performance StatusMaleMiddle AgedNeoplasm GradingAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabIndolesnintedanibReceptor Protein-Tyrosine Kinases

Identifiers

PMID25338318
OpenAlexW2077876620

What OpenQuestion holds

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Read underepoch 390

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.