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GSK2110183

Phase 2

Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Jul 9, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01531894Continuation Study of the Oral AKT Inhibitor GSK2110183PHASE2 COMPLETED 11Feb 8, 2012Jun 20, 2018Jul 9, 20198 United States, Australia +3
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Study Endpoints
Primary Endpoints
Number of Participants With at Least One Adverse Events (AEs)
from the time of consent until the final study visit up to approx. 76 months

Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK2110183 (afuresertib)EXPERIMENTALAll patients received the GSK2110183 (afuresertib) treatment
Interventions
NameTypeDescription
GSK2110183 (afuresertib)DRUGAfuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Has provided signed informed consent for this study. * Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK. * Currently benefitting fro...

Countries:United StatesAustraliaCanadaIrelandSouth Korea
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