Evidence map›Paper›PMID 37919668›Full record

Trial reportBMC cancer2023

Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study.

Do-Youn Oh, Maria Alsina Maqueda, David I Quinn, Peter J O'Dwyer, Ian Chau, Sun Young Kim, Ignacio Duran, Daniel Castellano, Jordan Berlin, Begona Mellado and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02599324 (A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal and Genitourinary Tumors), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 32% 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.

NCT02599324 phase1 / phase2completednot on this map

A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal and Genitourinary Tumors

TypeinterventionalSponsorPharmacyclics LLC.Ran2015 to 2021Enrolled263ConditionsMetastatic Renal Cell Carcinoma, Advanced Urothelial Carcinoma, Advanced Gastric Adenocarcinoma, Metastatic Colorectal AdenocarcinomaArmsibrutinib, everolimus, paclitaxel, docetaxel, cetuximab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. 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

20 authors at 19 institutions in 4 countries.

Do-Youn OhSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Graduate School, Seoul, South Korea. ohdoyoun@snu.ac.kr.
Maria Alsina MaquedaVall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
David I QuinnUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Peter J O'DwyerUniversity of Pennsylvania, Philadelphia, PA, USA.
Ian ChauThe Royal Marsden NHS Foundation Trust-Royal Marsden Hospital, London, UK.
Sun Young KimAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Ignacio DuranHospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
Daniel CastellanoHospital Universitario, 12 de Octubre, Madrid, Spain.
Jordan BerlinVanderbilt-Ingram Cancer Center, Nashville, TN, USA.
Begona MelladoMedical Oncology Department, Hospital Clinic i Provincial de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.
Stephen K WilliamsonUniversity of Kansas Hospital Cancer Center, Kansas City, KS, USA.
Keun-Wook LeeSeoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Francisca MartiThe Christie NHS Foundation Trust, Manchester, UK.
Paul MathewTufts Medical Center, Boston, MA, USA.
Muhammad Wasif SaifTufts Medical Center, Boston, MA, USA.
Ding WangHenry Ford Hospital, Detroit, MI, USA.
Elizabeth ChongPharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
Jacqueline Hilger-RolfePharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
James P DeanPharmacyclics LLC, an AbbVie Company, South San Francisco, CA, USA.
Hendrik-Tobias ArkenauSarah Cannon Research Institute - United Kingdom (SCRI-UK) and University College London, Cancer Institute, London, UK.
Pharmacyclics (United States) · USAbbVie (United States) · USHenry Ford Hospital · USHospital Universitario 12 De Octubre · ESInstituto de Investigación Marqués de Valdecilla · ESLondon Cancer · GBOrlando Health · USRoyal Marsden NHS Foundation Trust · GBSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRThe Christie NHS Foundation Trust · GBThe University of Kansas Health System · USTufts Medical Center · USUlsan College · KRUniversitat de Barcelona · ESUniversity of Pennsylvania · USUniversity of Southern California · USVall d'Hebron Institute of OncologyVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIbrutinib, a first-in-class inhibitor of Bruton's tyrosine kinase, is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. Based on encouraging preclinical data, safety and efficacy of ibrutinib combined with companion drugs for advanced renal cell carcinoma (RCC), gastric/gastroesophageal junctional adenocarcinoma (GC), and colorectal adenocarcinoma (CRC) were evaluated.

methodsIbrutinib 560 mg or 840 mg once daily was administered with standard doses of everolimus for RCC, docetaxel for GC, and cetuximab for CRC. Endpoints included determination of the recommended phase 2 dose (RP2D) of ibrutinib in phase 1b and efficacy (overall response rate [ORR] for GC and CRC; progression-free survival [PFS] for CRC) in phase 2.

resultsA total of 39 (RCC), 46 (GC), and 50 (RCC) patients were enrolled and received the RP2D. Safety profiles were consistent with the individual agents used in the study. Confirmed ORRs were 3% (RCC), 21% (GC), and 19% (CRC). Median (90% CI) PFS was 5.6 (3.9-7.5) months in RCC, 4.0 (2.7-4.2) months in GC, and 5.4 (4.1-5.8) months in CRC.

conclusionsClinically meaningful increases in efficacy were not observed compared to historical controls; however, the data may warrant further evaluation of ibrutinib combinations in other solid tumours.

trial registrationClinicalTrials.gov, NCT02599324.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAdenineAntineoplastic Combined Chemotherapy ProtocolsHumansPiperidinesAdenineibrutinibPiperidinesCetuximabColorectal carcinomaDocetaxelEverolimusGastric adenocarcinomaIbrutinibRenal cell carcinoma

Identifiers

PMID37919668
PMCPMC10623721
OpenAlexW4388248392

What OpenQuestion holds

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LicenceCC BY
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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.