NCT01395004

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Langerhans Cell Histiocytosis

Interventions

Type	Name	Description
DRUG	GSK2110183	GSK2110183 was orally administered at 125 mg once daily.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-07-15
• Last updated: 2020-09-09

Locations

5 sites across 1 country: United States