Clinical Trial: A Study to Test the Ability of and Safety of GSK2110183 in Treating Langerhans Cell Histiocytosis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase 2a, Open Label, Multicenter Study to Assess the Efficacy and Safety of the Oral AKT Inhibitor GSK2110183 in Subjects With Langerhans Cell Histiocytosis

Brief Summary: The purpose of this study is to assess safety and efficacy at months 3 and 6 in patients with Langerhans Cell Histiocytosis given daily oral doses of GSK2110183.

Detailed Summary: LCH115397 is a phase 2a, open label, multicenter study testing 125 mg (starting dose) daily oral GSK2110183 in adult and adolescent Langerhans Cell Histiocytosis patients. The primary objectives of the study are efficacy (at 3 and 6 months) and safety. For the purpose of efficacy analysis, patients will be stratified into two groups: treatment-naïve (stratum 1) and refractory or reactivation disease (stratum 2). Adolescent participation will be limited to patients with refractory or reactivation disease (stratum 2).
Sponsor: Accenture

Current Primary Outcome:

  • Objective disease response at 3 and 6 months [ Time Frame: every 12 weeks ]
  • Proportion of subjects experiencing greater than or equal to grade 3 neutropenia [ Time Frame: every 12 weeks ]
  • Proportion of patients who experience microbial infections [ Time Frame: every 12 weeks ]
  • Proportion of subjects experiencing newly diagnosed or worsening neuropathy [ Time Frame: every 12 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Accenture

Dates:
Date Received: July 12, 2011
Date Started: November 2011
Date Completion: June 2013
Last Updated: May 15, 2013
Last Verified: May 2013