Evidence map›Paper›PMID 41345097›Full record

Trial reportNature communications2025

Glasdegib in combination with temozolomide and radiotherapy in adult patients with newly diagnosed glioblastoma: the phase Ib/II GEINO 1602 trial.

María Ángeles Vaz-Salgado, Sonia Del Barco, Juan Manuel Sepúlveda, Miriam Alonso, Estela Pineda, Carmen Balana, María Martínez-García, Regina Gironés

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03466450 (Phase Ib/II Multicentric Study Combining Glasdegib), 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
–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.

NCT03466450 phase1 / phase2completednot on this map

Phase Ib/II Multicentric Study Combining Glasdegib (PF-04449913) With Temozolomide in Patients With Newly Diagnosed Glioblastoma, Safety and Preliminary Efficacy for the Combination

TypeinterventionalSponsorGrupo Español de Investigación en NeurooncologíaRan2018 to 2023Enrolled75ConditionsGlioblastomaArmsPF-04449913, Temozolomide Oral Capsule
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  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

8 authors.

María Ángeles Vaz-SalgadoMedical Oncology Department, Hospital Universitario Ramón y Cajal, Biomarkers and Personalized Approach to Cancer Group (BioPAC), Instituto Ramón y Cajal de Investigación Sanitaria (Irycis), Madrid, Spain. mavaz4@gmail.com.ORCID http://orcid.org/0000-0002-5913-9002
Sonia Del BarcoMedical Oncology Department, Institut Català d'Oncologia Girona, Girona, Spain.ORCID http://orcid.org/0000-0002-4951-6871
Juan Manuel SepúlvedaMedical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Miriam AlonsoMedical Oncology Department, Hospital Virgen del Rocío, Sevilla, Spain.
Estela PinedaMedical Oncology Department Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain.
Carmen BalanaMedical Oncology Department, Institut Català d'Oncologia, Badalona, Spain.ORCID http://orcid.org/0000-0003-0771-0390
María Martínez-GarcíaMedical Oncology Department, Hospital del Mar, Barcelona, Spain.
Regina GironésMedical Oncology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.

Funding

Pfizer (Pfizer Inc.) Not applicable
6 · The paper itself

Abstract

The hedgehog pathway is implicated in resistance to anticancer therapies in glioblastoma (GB). GEINO1602 (NCT03466450) phase Ib/II study evaluated the safety and efficacy of glasdegib and the Stupp scheme in newly diagnosed GB. Patients received glasdegib with radiotherapy plus concomitant and 6 cycles of adjuvant temozolomide followed by glasdegib monotherapy. The recommended phase 2 dose was 75 mg/day of glasdegib. The primary endpoint was the 15-months overall survival (OS), with a futility threshold of 60% to consider the trial positive; accrual required 70 evaluable patients. 79 patients were enrolled. The 15 m OS rate was 52.1% (95% CI: 41.7-65.2). At 2 years, 29.2% of the patients were still alive. The median progression-free survival (PFS) was 7.1 months (95% CI: 6.2-8.6). Glasdegib plus chemoradiotherapy show preliminary efficacy. Despite not surpassing the futility threshold, 30% lived at the data cutoff. Translational research will help define the molecular traits of long-term survivors.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBrain NeoplasmsChemoradiotherapyGlioblastomaPhenylurea CompoundsTemozolomideAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalTreatment OutcomeBenzimidazolesglasdegibPhenylurea CompoundsTemozolomide

Identifiers

PMID41345097
PMCPMC12769667

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.