title: The fate of camptothecin glycoconjugate: report of a clinical hold during a phase II study of BAY 56-3722 (formerly BAY 38-3441), in patients with recurrent or metastatic colorectal cancer resistant/refractory to irinotecan.
abstract: BACKGROUND
  BAY 56-3722 (formerly BAY 38-3441) is a glycoconjugated campthotecin, which was considered an attractive drug to assess in colorectal cancer (CRC).
  
  
  METHODS
  Phase II study design evaluating the antitumor activity of BAY 56-3722 i.v. 320 mg/m(2) daily for 3 days every 3 weeks in patients with recurrent or metastatic inoperable CRC resistant to irinotecan.
  
  
  RESULTS
  Twenty-four patients received the study treatment. Triggered by adverse events in two other studies with this compound the study was put on a clinical hold while the safety data were reviewed for the entire program. After the review Bayer decided to withdraw BAY 56-3722 from all clinical investigations.
  
  
  CONCLUSIONS
  We felt it was our obligation to share this interrupted phase II study for two reasons: to report the fate of camptothecin glycoconjugate and to report the unique situation of a clinical hold during a phase II study.
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. m.slingerland@lumc.nl
authors.forename: Marije
authors.initials: M
authors.lastname: Slingerland
authors.forename: Hans
authors.initials: H
authors.lastname: Gelderblom
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D006801:Humans; D000077146:Irinotecan
chemical_list: C440617:20-O-(Nalpha-(4-(3-O-methylfucopyranosyloxy)phenylaminothiocarbonyl)histidylvalyl)camptothecin; D000970:Antineoplastic Agents; D004151:Dipeptides; D000077146:Irinotecan; D002166:Camptothecin