Trial reportNeuro-oncology2016
A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph
Trial report in Neuro-oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01582269 (A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma), which is not on this map. Cited by 153 papers, 6 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
153citing papers in PubMed, 6 pooled it
13.7field-weighted citation impact, top 1% of its field
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.
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.
A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma
Who cites it
153 citing papers in PubMed, 6 syntheses or guidelines pooled it, 267 citations in OpenAlex.
- Comparative efficacy of therapeutic strategies for recurrent or refractory glioblastoma: a systematic review and network meta-analysis.Frontiers in neurology · 2026Pooled it
- Identifying the best treatment choice for relapsing/refractory glioblastoma: a systematic review with multiple Bayesian network meta-analyses.The oncologist · 2025Pooled it
- Targeted agents in patients with progressive glioblastoma-A systematic meta-analysis of randomized clinical trials.Cancer medicine · 2024Pooled it
- Congress of Neurological Surgeons systematic review and evidence-based guidelines update on the role of targeted therapies and immunotherapies in the management of progressive glioblastoma.Journal of neuro-oncology · 2022Pooled it
- Treatment options for progression or recurrence of glioblastoma: a network meta-analysis.The Cochrane database of systematic reviews · 2021Pooled it
- Optimal Therapies for Recurrent Glioblastoma: A Bayesian Network Meta-Analysis.Frontiers in oncology · 2021Pooled it
- The STELLAR trial: a phase II/III randomized trial of high-dose, intermittent sunitinib in patients with recurrent glioblastoma.Brain communications · 2024Trial
- Trial
- Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer.Journal for immunotherapy of cancer · 2021Trial
- Phase 1b/2a study of galunisertib, a small molecule inhibitor of transforming growth factor-beta receptor I, in combination with standard temozolomide-based radiochemotherapy in patients with newly diagnosed malignant glioma.Investigational new drugs · 2020Trial
- A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma.The oncologist · 2019Trial
- Biomarker and Histopathology Evaluation of Patients with Recurrent Glioblastoma Treated with Galunisertib, Lomustine, or the Combination of Galunisertib and Lomustine.International journal of molecular sciences · 2017Trial
- Key regulatory elements of the TGFβ-LRRC15 axis predict disease progression and immunotherapy resistance across cancer types.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- ROS-autocatalytic nanoplatform interfering astrocyte-cancer crosstalk and enhancing glioblastoma therapy.Nature communications · 2026Article
- The Invasive Margin of Glioblastoma as a Molecular Ecosystem: Spatial Heterogeneity, Tumor-Host Interactions, and Therapeutic Opportunities.International journal of molecular sciences · 2026Review
- Article
- Cytokines and cancer-associated fibroblasts.Journal of hematology & oncology · 2026Review
- Modeling glioblastoma relapse in vitro: a critical journey from 2D models to organ-on-chip alternatives.NPJ precision oncology · 2026Review
- Potent antitumor activity through dual targeting of PD-L1 and TGF-β pathways in the glioma tumor microenvironment.Journal for immunotherapy of cancer · 2026Article
- Macrophage plasticity in thyroid eye disease: dual effects of inflammation and fibrosis.Frontiers in immunology · 2026Review
93 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 5 institutions in 3 countries.
Alba A BrandesMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Antoine F CarpentierMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Santosh KesariMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Juan M Sepulveda-SanchezMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Helen R WheelerMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Olivier ChinotMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Lawrence CherMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Joachim P SteinbachMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
David CapperMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Pol SpecenierMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Jordi RodonMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Ann CleverlyMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Claire SmithMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Ivelina GueorguievaMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Colin MilesMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Susan C GubaMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Durisala DesaiahMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Michael M LahnMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Wolfgang WickMedical Oncology Department, Bellaria-Maggiore Hospitals, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B.); Hôpital Avicenne, Paris 13 University, Bobigny, France (A.F.C.); University of California San Diego Health System, La Jolla, California (S.K.); Hospital Universitario 12 de Octubre, Madrid, Spain (J.M.S.-S.); Department of Oncology, Royal North Shore Hospital, St Leonards, Australia (H.R.W.); CHU Hôspital De La Timone, Rue Saint Pierre, France (O.C.); Austin Hospital, Heidelberg, Australia (L.C.); Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Frankfurt, Germany (J.P.S.); Department of Neuropathology, University Hospital Heidelberg, Heidelberg, Germany (D.C.); Antwerp University Hospital, Edegem, Belgium (P.S.); Medical Oncology, Vall d'Hebron University Hospital and Universitat Autònoma de Barcelona, Barcelona, Spain (J.R.); Eli Lilly and Company, Erl Wood, England (A.C., C.S., I.G., C.M.); Eli Lilly and Company, Indianapolis, Indiana (S.C.G., D.D., M.M.L.); Neurology Clinic, University of Heidelberg, Heidelberg, Germany (W.W.).
Institute of Neurological Sciences · ITHeidelberg University · DEUniversity Hospital Heidelberg · DEGoethe University Frankfurt · DEUniversité Sorbonne Paris Nord · FR
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe combination of galunisertib, a transforming growth factor (TGF)-β receptor (R)1 kinase inhibitor, and lomustine was found to have antitumor activity in murine models of glioblastoma.
methodsGalunisertib (300 mg/day) was given orally 14 days on/14 days off (intermittent dosing). Lomustine was given as approved. Patients were randomized in a 2:1:1 ratio to galunisertib + lomustine, galunisertib monotherapy, or placebo + lomustine. The primary objective was overall survival (OS); secondary objectives were safety, pharmacokinetics (PKs), and antitumor activity.
resultsOne hundred fifty-eight patients were randomized: galunisertib + lomustine (N = 79), galunisertib (N = 39), and placebo + lomustine (N = 40). Baseline characteristics were: male (64.6%), white (75.3%), median age 58 years, ECOG performance status (PS) 1 (63.3%), and primary glioblastoma (93.7%). The PKs of galunisertib were not altered with lomustine, and galunisertib had a median half-life of ∼8 hours. Median OS in months (95% credible interval [CrI]) for galunisertib + lomustine was 6.7 (range: 5.3-8.5), 8.0 (range: 5.7-11.7) for galunisertib alone, and 7.5 (range: 5.6-10.3) for placebo + lomustine. There was no difference in OS for patients treated with galunisertib + lomustine compared with placebo + lomustine [P (HR < 1) = 26%]. Median progression-free survival of ∼2 months was observed in all 3 arms. Among 8 patients with IDH1 mutation, 7 patients were treated with galunisertib (monotherapy or with lomustine); OS ranged from 4 to 17 months. Patients treated with galunisertib alone had fewer drug-related grade 3/4 adverse events (n = 34) compared with lomustine-treated patients (10% vs 26%). Baseline PS, post-discontinuation of bevacizumab, tumor size, and baseline levels of MDC/CCL22 were correlated with OS.
conclusionsGalunisertib + lomustine failed to demonstrate improved OS relative to placebo + lomustine. Efficacy outcomes were similar in all 3 arms. CLINICAL
trial registrationNCT01582269, ClinicalTrials.gov.
Indexed as
Antineoplastic Agents, AlkylatingBrain NeoplasmsDisease-Free SurvivalDrug Therapy, CombinationFemaleGlioblastomaHumansKaplan-Meier EstimateLomustineMaleMiddle AgedPyrazolesQuinolinesTreatment OutcomeAntineoplastic Agents, AlkylatingLomustineLY-2157299PyrazolesQuinolinesantitumor activityBayesian designgalunisertib monohydrate (LY2157299)pharmacokineticsPhase II randomized studysafety
Identifiers
What OpenQuestion holds
Textmetadata
Read underepoch 390
Registered trials
NCT01582269ClinicalTrials.gov
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.