title: A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma.
abstract: The 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.
  
  
  
  Galunisertib (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.
  
  
  
  One 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.
  
  
  
  Galunisertib + lomustine failed to demonstrate improved OS relative to placebo + lomustine. Efficacy outcomes were similar in all 3 arms.
  
  
  
  NCT01582269, ClinicalTrials.gov.
authors.affiliation: Medical 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.).
authors.forename: Alba A
authors.initials: AA
authors.lastname: Brandes
authors.affiliation: Medical 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.).
authors.forename: Antoine F
authors.initials: AF
authors.lastname: Carpentier
authors.affiliation: Medical 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.).
authors.forename: Santosh
authors.initials: S
authors.lastname: Kesari
authors.affiliation: Medical 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.).
authors.forename: Juan M
authors.initials: JM
authors.lastname: Sepulveda-Sanchez
authors.affiliation: Medical 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.).
authors.forename: Helen R
authors.initials: HR
authors.lastname: Wheeler
authors.affiliation: Medical 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.).
authors.forename: Olivier
authors.initials: O
authors.lastname: Chinot
authors.affiliation: Medical 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.).
authors.forename: Lawrence
authors.initials: L
authors.lastname: Cher
authors.affiliation: Medical 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.).
authors.forename: Joachim P
authors.initials: JP
authors.lastname: Steinbach
authors.affiliation: Medical 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.).
authors.forename: David
authors.initials: D
authors.lastname: Capper
authors.affiliation: Medical 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.).
authors.forename: Pol
authors.initials: P
authors.lastname: Specenier
authors.affiliation: Medical 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.).
authors.forename: Jordi
authors.initials: J
authors.lastname: Rodon
authors.affiliation: Medical 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.).
authors.forename: Ann
authors.initials: A
authors.lastname: Cleverly
authors.affiliation: Medical 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.).
authors.forename: Claire
authors.initials: C
authors.lastname: Smith
authors.affiliation: Medical 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.).
authors.forename: Ivelina
authors.initials: I
authors.lastname: Gueorguieva
authors.affiliation: Medical 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.).
authors.forename: Colin
authors.initials: C
authors.lastname: Miles
authors.affiliation: Medical 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.).
authors.forename: Susan C
authors.initials: SC
authors.lastname: Guba
authors.affiliation: Medical 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.).
authors.forename: Durisala
authors.initials: D
authors.lastname: Desaiah
authors.affiliation: Medical 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.).
authors.forename: Michael M
authors.initials: MM
authors.lastname: Lahn
authors.affiliation: Medical 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.).
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Wick
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008130:Lomustine / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011804:Quinolines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D011720:Pyrazoles; D011804:Quinolines; C557799:LY-2157299; D008130:Lomustine
keywords: Bayesian design; Phase II randomized study; antitumor activity; galunisertib monohydrate (LY2157299); pharmacokinetics; safety