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GSK2110183

Phase 2

Langerhans Cell Histiocytosis | Small molecule | Rare Disease |GSK plc|Last Updated: Sep 9, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

GSK2110183 · 1 trial · 1 indication

Phase 2 1
NCT01395004A Study to Test the Ability of and Safety of GSK2110183 in Treating Langerhans Cell HistiocytosisLangerhans Cell Histiocytosis
COMPLETED17 Analytics
PHASE2COMPLETED
A Study to Test the Ability of and Safety of GSK2110183 in Treating Langerhans Cell Histiocytosis
Langerhans Cell HistiocytosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective disease response at 3 and 6 months
Up to 6 months
Proportion of subjects experiencing greater than or equal to grade 3 neutropenia
Up to week 53
Proportion of patients who experience microbial infections
Up to week 53
Proportion of subjects experiencing newly diagnosed or worsening neuropathy
Up to week 53
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Active Drug - GSK2110183EXPERIMENTALThis was an open-label study of oral GSK211083 administered at the maximum tolerated dose of 125 mg once daily.

Interventions

NameTypeDescription
GSK2110183DRUGGSK2110183 was orally administered at 125 mg once daily.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Written informed consent is provided. Adolescents will provide assent, with consent provided by parent or legal guardian. 2. Prior therapy restrictions: * Refractory/reactivation stratum: Age \>= 12 years of age at the time of study enrollment and Tanner Stage \>2. Subjec...

Countries:United States
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Frequently asked questions about GSK2110183

What is GSK2110183 used for?

GSK2110183 is an investigational small molecule being studied for the treatment of Langerhans Cell Histiocytosis, a rare disease. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes GSK2110183?

GSK2110183 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 2 clinical trials for Langerhans Cell Histiocytosis.

What phase is GSK2110183 in?

GSK2110183 is in Phase 2 clinical development. It is an investigational drug being studied for Langerhans Cell Histiocytosis and is not yet approved for any use.

What clinical trials is GSK2110183 in?

GSK2110183 has one completed Phase 2 clinical trial, NCT01395004, which studied the drug in 17 patients with Langerhans Cell Histiocytosis in the United States. The trial was not randomized or double-blinded and had no control group.

Is GSK2110183 the same as any other drug?

GSK2110183 is the primary name for this investigational drug. No alternative names have been reported for this compound in the context of its clinical development for Langerhans Cell Histiocytosis.