Evidence map›Paper›PMID 32147671›Full record

ArticleBritish journal of cancer2020

Imatinib in combination with phosphoinositol kinase inhibitor buparlisib in patients with gastrointestinal stromal tumour who failed prior therapy with imatinib and sunitinib: a Phase 1b, multicentre study.

Hans Gelderblom, Robin L Jones, Suzanne George, Claudia Valverde Morales, Charlotte Benson, Jean-Yves Blay, Daniel J Renouf, Toshihiko Doi, Axel Le Cesne, Michael Leahy and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01468688 (A Multi-arm Dose-finding Phase Ib Multicenter Study of Imatinib in Combination With the Oral Phosphatidyl-inositol 3-kinase), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.7field-weighted citation impact, top 9% 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.

NCT01468688 phase1completednot on this map

A Multi-arm Dose-finding Phase Ib Multicenter Study of Imatinib in Combination With the Oral Phosphatidyl-inositol 3-kinase (PI3-K) Inhibitor BKM120 in Patients With Gastrointestinal Stromal Tumor (GIST) Who Failed Prior Therapy With Imatinib and Sunitinib

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2016Enrolled60Conditions3rd Line GISTArmsSTI571, BKM120
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 23 citations in OpenAlex.

  1. Review
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  4. Article
  5. PersonalizedJCO precision oncology · 2025
    Observational
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  16. The role of KRAS splice variants in cancer biology.Frontiers in cell and developmental biology · 2022
    Review
  17. Review
  18. PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.International journal of molecular sciences · 2021
    Review
  19. Review
  20. Review
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

14 authors at 10 institutions in 8 countries.

Hans GelderblomLeiden University Medical Center, Leiden, The Netherlands. a.j.gelderblom@lumc.nl.
Robin L JonesThe Royal Marsden Hospital and Institute of Cancer Research, London, UK.
Suzanne GeorgeDana-Farber Cancer Institute Boston, Boston, MA, USA.
Claudia Valverde MoralesVall D'Hebron University Hospital, Barcelona, Spain.
Charlotte BensonThe Royal Marsden Hospital, London, UK.
Jean-Yves BlayCentre Léon Bérard, Lyon, France.
Daniel J RenoufBC Cancer - Vancouver Centre, Vancouver, Canada.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Japan.
Axel Le CesneInstitut Gustave Roussy, Villejuif Cedex, France.
Michael LeahyThe Christie Hospital, Manchester, UK.
Sabine HertleNovartis Pharma AG, Basel, Switzerland.
Paola AimoneNovartis Pharma AG, Basel, Switzerland.
Ulrike BrandtNovartis Pharma AG, Basel, Switzerland.
Patrick SchӧffskiUniversity Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.
Novartis (Switzerland) · CHRoyal Marsden Hospital · GBDana-Farber Cancer Institute · USInstitut Gustave Roussy · FRKU Leuven · BELeiden University Medical Center · NLNational Cancer Center Hospital East · JPThe Christie Hospital · GBUniCancer Group · FRVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe majority of patients with advanced gastrointestinal stromal tumours (GISTs) develop resistance to imatinib and sunitinib, the standard of care for these patients. This study evaluated the combination of buparlisib, an oral phosphoinositide 3-kinase (PI3K) inhibitor, with imatinib in patients with advanced GIST, who have failed prior therapy with imatinib and sunitinib.

methodsThis Phase 1b, multicentre, open-label study aimed to determine the maximum tolerated dose (MTD) and/or a recommended Phase 2 dose of buparlisib in combination with 400 mg of imatinib through a dose-escalation part and a dose-expansion part, and also evaluated the clinical profile of the combination.

resultsSixty patients were enrolled, including 25 in the dose-escalation part and 35 in the dose-expansion part. In the combination, MTD of buparlisib was established as 80 mg. No partial or complete responses were observed. The estimated median progression-free survival was 3.5 months in the expansion phase. Overall, 98.3% of patients had treatment-related adverse events (AEs), including 45% with grade 3 or 4 AEs.

conclusionsBuparlisib in combination with imatinib provided no additional benefit compared with currently available therapies. Due to the lack of objective responses, further development of this combination was not pursued for third-line/fourth-line advanced/metastatic GIST. TRIAL REGISTRATION NUMBER: NCT01468688.

Indexed as

AdultAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsFemaleGastrointestinal NeoplasmsGastrointestinal Stromal TumorsHumansImatinib MesylateMaleMental DisordersMiddle AgedMorpholinesPhosphoinositide-3 Kinase InhibitorsSunitinibAminopyridinesImatinib MesylateMorpholinesNVP-BKM120Phosphoinositide-3 Kinase InhibitorsSunitinib

Identifiers

PMID32147671
PMCPMC7156686
OpenAlexW3010234595

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.