Evidence map›Paper›PMID 32665311›Full record

Trial reportESMO open2020

Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study.

Mark Rosenthal, Paul M Clement, Mario Campone, Miguel J Gil-Gil, John DeGroot, Olivier Chinot, Ahmed Idbaih, Hui Gan, Jeffrey Raizer, Patrick Yung Wen and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01934361 (Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT01934361 phase1completednot on this map

Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

TypeinterventionalSponsorNovartis PharmaceuticalsRan2014 to 2016Enrolled35ConditionsRecurrent Glioblastoma MultiformeArmsbuparlisib, carboplatin, lomustine, placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. International journal of molecular sciences · 2025
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Article
  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

15 authors at 14 institutions in 6 countries.

Mark RosenthalMedical Oncology, Royal Melbourne Hospital, Melbourne, Victoria, Australia mark.rosenthal@petermac.org.ORCID 0000-0003-1152-6764
Paul M ClementDepartment of Oncology, Leuven Cancer Institute, Leuven, Belgium.
Mario CamponeInstitut de Cancérologie de l'Ouest, Centre René Gauducheau, Saint Herblain, Pays de la Loire, France.
Miguel J Gil-GilInstitut Català d'Oncologia, Barcelona, Spain.
John DeGrootDepartment of Neuro-Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Olivier ChinotDepartment of Neuro-Oncology, Assistance Publique - Hôpitaux de Marseille Office Central des Bibliothèques, Marseille, Provence-Alpes-Côte d'Azur, France.
Ahmed IdbaihDepartment of Neuro-Oncology, Sorbonne Université, Paris, Île-de-France, France.
Hui GanOncology, Olivia Newton-John Cancer & Wellness Centre, Heidelberg, Victoria, Australia.
Jeffrey RaizerDepartment of Neuro-Oncology, Northwestern Medical Faculty Foundation, Chicago, Illinois, USA.
Patrick Yung WenDepartment of Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0002-0774-7700
Estela PinedaMedical Oncology, University of Barcelona Faculty of Medicine and Health Sciences, Barcelona, Catalunya, Spain.
Valerie DonnetNovartis Pharma SAS, Paris, France.
David MillsNovartis Pharma, Basel, Basel-Stadt, Switzerland.
Mona El-HashimyNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Warren MasonDepartment of Oncology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
Assistance Publique Hôpitaux de Marseille · FRDana-Farber Cancer Institute · USInstitut Català d'Oncologia · ESInstitut de Cancérologie de l'Ouest · FRNorthwestern Medical Faculty Foundation · USNovartis (France) · FRNovartis (Switzerland) · CHNovartis (United States) · USOlivia Newton-John Cancer Wellness & Research Centre · AUPrincess Margaret Cancer Centre · CASorbonne Université · FRThe Royal Melbourne Hospital · AUThe University of Texas MD Anderson Cancer Center · USUniversitat de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlioblastoma relapse is associated with activation of phosphatidylinositol 3-kinase (PI3K) signalling pathway. In preclinical studies, the pan-PI3K inhibitor buparlisib showed antitumour activity in glioma models.

methodsThis was a two-part, multicentre, phase Ib/II study in patients with recurrent glioblastoma pretreated with radiotherapy and temozolomide standard of care. Patients received buparlisib (80 mg or 100 mg once daily) plus carboplatin (area under the curve (AUC)=5 every 3 weeks), or buparlisib (60 mg once daily) plus lomustine (100 mg/m

resultsBetween 28 February 2014 and 7 July 2016, 35 patients were enrolled and treated with buparlisib plus carboplatin (n=17; buparlisib (80 mg) plus carboplatin, n=3; and buparlisib (100 mg) plus carboplatin, n=14), or buparlisib (60 mg) plus lomustine (n=18). The MTD of buparlisib was determined to be 100 mg per day in combination with carboplatin at an AUC of 5 every 3 weeks. The MTD of buparlisib in combination with lomustine could not be determined as it did not satisfy the MTD criteria per the Bayesian logistic regression model.

conclusionThe overall safety profile of buparlisib remained unchanged, and no new or unexpected safety findings were reported in this study. Preliminary assessment for both combinations did not demonstrate sufficient antitumour activity compared with historical data on single-agent carboplatin or lomustine. TRIAL REGISTRATION NUMBER: NCT01934361.

Indexed as

GlioblastomaAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBayes TheoremCarboplatinFemaleHumansLomustineMaleMiddle AgedMorpholinesPhosphatidylinositol 3-KinasesRecurrenceAminopyridinesCarboplatinLomustineMorpholinesNVP-BKM120Phosphatidylinositol 3-KinasesBKM120buparlisibrecurrent glioblastomarGBM

Identifiers

PMID32665311
PMCPMC7359195
OpenAlexW3043725666

What OpenQuestion holds

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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.