title: An open-label, phase II study of the polo-like kinase-1 (Plk-1) inhibitor, BI 2536, in patients with relapsed small cell lung cancer (SCLC).
abstract: This phase II, open-label study was designed to evaluate the response rate to the polo-like kinase 1 (Plk-1) inhibitor BI 2536 in patients with sensitive-relapsed small cell lung cancer (SCLC). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, and safety.
  
  
  
  Patients were treated with the recommended phase II dose of 200mg of BI 2536 intravenously every 21days. This was a two-stage design with an early stopping rule in place if responses were not seen in at least 2 of the first 18 enrolled patients.
  
  
  
  Twenty-three patients were enrolled in the study and 21 patients were evaluable for response. No responses were observed and all 23 patients have progressed. The median PFS was 1.4 months. Treatment was generally well tolerated and the most frequent adverse events were neutropenia, fatigue, nausea, vomiting, and constipation. BI 2536 is not effective in the treatment of sensitive relapsed SCLC. The criteria for expanding the trial to the second stage were not achieved, and the study was terminated for a lack of efficacy.
authors.affiliation: Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
authors.forename: Mark M
authors.initials: MM
authors.lastname: Awad
authors.affiliation: Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Quincy S-C
authors.initials: QS
authors.lastname: Chu
authors.affiliation: Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
authors.forename: Leena
authors.initials: L
authors.lastname: Gandhi
authors.affiliation: Cancer Centers of the Carolinas, Greenville, SC, USA.
authors.forename: Joe J
authors.initials: JJ
authors.lastname: Stephenson
authors.affiliation: Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Ramaswamy
authors.initials: R
authors.lastname: Govindan
authors.affiliation: Highlands Oncology Group, Fayetteville, AR, USA.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Bradford
authors.affiliation: Rush University Medical Center, Chicago, IL, USA.
authors.forename: Philip D
authors.initials: PD
authors.lastname: Bonomi
authors.affiliation: Charleston Hematology Oncology Associates, Charleston, SC, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Ellison
authors.affiliation: Seattle Cancer Care Alliance, Seattle, WA, USA.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Eaton
authors.affiliation: Boehringer Ingelheim, Biberach, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Fritsch
authors.affiliation: Boehringer Ingelheim, Biberach, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Munzert
authors.affiliation: Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: bruce_johnson@dfci.harvard.edu.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Johnson
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D018797:Cell Cycle Proteins / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D017346:Protein Serine-Threonine Kinases / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D011518:Proto-Oncogene Proteins / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D011621:Pteridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D012008:Recurrence; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D012907:Smoking / Q000453:epidemiology; D017211:Treatment Failure; D016896:Treatment Outcome; D000097869:Polo-Like Kinase 1
chemical_list: D018797:Cell Cycle Proteins; D017346:Protein Serine-Threonine Kinases; D011518:Proto-Oncogene Proteins; D011621:Pteridines; D000097869:Polo-Like Kinase 1; C518477:BI 2536
keywords: BI 2536; Plk-1 inhibition; Polo-like kinase; Small cell lung cancer