Recent Updates
Recently added Catalysts

GSK2110183

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01395004A Study to Test the Ability of and Safety of GSK2110183 in Treating Langerhans Cell HistiocytosisPHASE2 COMPLETED 17 — — Nov 1, 2011Nov 1, 2013Sep 9, 20205 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range12 Years — 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
Unlock Eligibility Criteria