title: A phase I study of oral panobinostat (LBH589) in Japanese patients with advanced solid tumors.
abstract: OBJECTIVE
  The objective was to determine the maximum tolerated dose and the dose-limiting toxicity of panobinostat (LBH589) when administered as a single agent to adult patients with advanced solid tumors or cutaneous T-cell lymphoma whose disease had progressed despite standard therapy or for whom no standard therapy existed.
  
  
  METHODS
  Panobinostat was administered orally once daily on Monday, Wednesday, and Friday of each week. A total of 13 patients were treated with one of three initial doses: 10 mg (n = 3), 15 mg (n = 4), or 20 mg (n = 6).
  
  
  RESULTS
  No dose-limiting toxicity was observed in 12 evaluable patients. The most frequently reported adverse events, regardless of whether they were related to the study drug, were diarrhea and nausea in 10 patients (76.9%). Thrombocytopenia was reported in 12 of 13 patients (92.3%). Five of 11 patients (45.4%) had stable disease.
  
  
  CONCLUSIONS
  Panobinostat administered orally once daily on Monday, Wednesday, and Friday of each week was well tolerated at doses up to 20 mg in Japanese patients. Dose escalation did not proceed after exploration of the 20 mg dose due to emerging global clinical data at that time.
authors.affiliation: Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Fukutomi
authors.forename: Kiyohiko
authors.initials: K
authors.lastname: Hatake
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Sakura
authors.initials: S
authors.lastname: Sakajiri
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.forename: Hiromi
authors.initials: H
authors.lastname: Tanii
authors.forename: Ken
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D044466:Asian People; D001772:Blood Cell Count; D005260:Female; D056572:Histone Deacetylase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D006877:Hydroxamic Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D007211:Indoles; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy*; D000077767:Panobinostat
chemical_list: D000970:Antineoplastic Agents; D056572:Histone Deacetylase Inhibitors; D006877:Hydroxamic Acids; D007211:Indoles; D000077767:Panobinostat