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GSK2141795

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Nov 13, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00920257A Phase I, Open-Label, First-Time-In-Human Study of the Oral AKT Inhibitor GSK2141795PHASE1 COMPLETED 77Jun 16, 2009Apr 17, 2013Nov 13, 20177 United States, Canada
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Study Endpoints
Primary Endpoints
To determine the recommended Phase II dose and schedule of GSK214179 using the following information: safety and tolerability, pharmacokinetic (single and repeat dose administration) and pharmacodynamic data
Continune until disease progression or consent withdrawn
Secondary Endpoints
• To explore the clinical efficacy of GSK2141795 in subjects with solid tumor malignancies or lymphomas
Continune until disease progression or consent withdrawn
To characterize the metabolite profile of oral GSK2141795 after repeat dose administration in subjects with solid tumor malignancies or lymphoma
Continune until disease progression or consent withdrawn
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK2141795EXPERIMENTALOral GSK214179 given daily to patients with cancer. Groups of approximately three patients will receive GSK2141795 at increasing doses until a maximum tolerated dose is identified.
Interventions
NameTypeDescription
GSK2141795DRUGGSK2141795 is an oral AKT inhibitor.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 18 years or older. * Histologically or cytologically confirmed diagnosis of solid tumor malignancy or lymphoma that is not...

Countries:United StatesCanada
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