Evidence map›Paper›PMID 31357193›Full record

Trial reportNeuroendocrinology2020

A Phase II Study of Ibrutinib in Advanced Neuroendocrine Neoplasms.

Taymeyah Al-Toubah, Michael J Schell, Mauro Cives, Jun-Min Zhou, Heloisa P Soares, Jonathan R Strosberg

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Neuroendocrinology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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

14 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Bruton's Tyrosine Kinase Inhibitors: Recent Updates.International journal of molecular sciences · 2024
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. 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

6 authors.

Taymeyah Al-ToubahDepartment of GI Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Michael J SchellDepartment of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Mauro CivesDepartment of Biomedical Sciences and Human Oncology, University of Bari, Bari, Italy.
Jun-Min ZhouDepartment of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Heloisa P SoaresDepartment of Oncology, University of New Mexico, Albuquerque, New Mexico, USA.
Jonathan R StrosbergDepartment of GI Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA, jonathan.strosberg@moffitt.org.

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundIbrutinib is an orally administered inhibitor of Bruton's tyrosine kinase (Btk). Preclinical data suggest that mast cells are recruited within neuroendocrine neoplasms (NENs) where they stimulate angiogenesis and tumor growth. Ibrutinib inhibits mast cell degranulation and has been associated with regression of tumors in a mouse insulinoma model.

methodsA prospective, phase II trial evaluated patients with advanced gastrointestinal (GI)/lung NENs and pancreatic NENs (pNENs) who had evidence of progression within 12 months of study entry on at least one prior therapy. Patients received ibrutinib 560 mg daily until unacceptable toxicity, progression of disease, or withdrawal of consent. The primary endpoint was objective response rate.

resultsTwenty patients were enrolled on protocol from November 2015 to December 2017 (15 advanced GI/lung NENs and 5 pNENs). No patient reached an objective response. Median PFS was 3.0 months. A total of 44 drug-related adverse events (AEs) were captured as probably or definitely associated with ibrutinib. Five patients experienced probably or definitely related grade 3 AEs, and 1 patient experienced a probably related grade 4 AE. Five patients discontinued treatment prior to radiographic assessment.

conclusionsIbrutinib does not show significant evidence of activity in well-differentiated gastroenteropancreatic and lung NENs.

Indexed as

AdenineAdultAgammaglobulinaemia Tyrosine KinaseAgedCarcinoid TumorFemaleGastrointestinal NeoplasmsHumansLung NeoplasmsMaleMiddle AgedNeuroendocrine TumorsPancreatic NeoplasmsPiperidinesProspective StudiesProtein Kinase InhibitorsAdenineAgammaglobulinaemia Tyrosine KinaseibrutinibPiperidinesProtein Kinase InhibitorsCarcinoid tumorIbrutinibNeuroendocrine neoplasmPancreatic neuroendocrine tumor

Identifiers

PMID31357193
PMCPMC7771542

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.