title: Phase II study of saracatinib (AZD0530) for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
abstract: BACKGROUND
  Saracatinib (AZD0530) is an orally available Src kinase inhibitor. A phase II study was conducted to evaluate saracatinib in patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC).
  
  
  METHODS
  This was an open-label, single-arm, phase II study. Patients received 175 mg saracatinib daily either orally or by percutaneous gastrostomy tube. Radiologic imaging for response was planned at the end of each eight-week cycle.
  
  
  RESULTS
  Nine patients were enrolled. All patients had received prior radiotherapy and six patients had received prior chemotherapy for recurrent or metastatic disease. The most common adverse event was fatigue. Eight patients had progression of disease by response evaluation criteria in solid tumors (RECIST) within the first eight-week cycle and one patient was removed from the study after 11 days due to clinical decline with stable disease according to the RECIST criteria. Median overall survival was six months. The study was closed early due to lack of efficacy according to the early stopping rule.
  
  
  CONCLUSIONS
  Single-agent saracatinib does not merit further study in recurrent or metastatic HNSCC.
authors.affiliation: Head and Neck Medical Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
authors.forename: Matthew G
authors.initials: MG
authors.lastname: Fury
authors.forename: Shrujal
authors.initials: S
authors.lastname: Baxi
authors.forename: Ronglai
authors.initials: R
authors.lastname: Shen
authors.forename: Katherine W
authors.initials: KW
authors.lastname: Kelly
authors.forename: Brynna L
authors.initials: BL
authors.lastname: Lipson
authors.forename: Diane
authors.initials: D
authors.lastname: Carlson
authors.forename: Hilda
authors.initials: H
authors.lastname: Stambuk
authors.forename: Sofia
authors.initials: S
authors.lastname: Haque
authors.forename: David G
authors.initials: DG
authors.lastname: Pfister
mesh_terms: D000328:Adult; D000368:Aged; D052117:Benzodioxoles / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011799:Quinazolines / Q000627:therapeutic use*; D015996:Survival Rate; D055815:Young Adult
chemical_list: D052117:Benzodioxoles; D011799:Quinazolines; C515233:saracatinib