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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01395004
Other study ID # 115397
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2011
Est. completion date November 2013

Study information

Verified date September 2020
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


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Study Design


Intervention

Drug:
GSK2110183
GSK2110183 was orally administered at 125 mg once daily.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States Baylor College of Medicine Houston Texas
United States Memorial Sloan Kettering Cancer Center New York New York
United States Staten Island University Hospital Staten Island New York

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective disease response at 3 and 6 months Up to 6 months
Primary Proportion of subjects experiencing greater than or equal to grade 3 neutropenia Up to week 53
Primary Proportion of patients who experience microbial infections Up to week 53
Primary Proportion of subjects experiencing newly diagnosed or worsening neuropathy Up to week 53
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