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GSK2126458

Phase 1

Solid Tumours | Small molecule | Oncology |GSK plc|Last Updated: May 9, 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 Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00972686Dose-Escalation Study of GSK2126458PHASE1 COMPLETED 79 — — Aug 31, 2009Mar 31, 2015May 9, 20179 United States, Netherlands
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Study Endpoints
Primary Endpoints
Adverse events (AEs) and changes in laboratory values and vital signs. Pharmacokinetic parameter values for GSK2126458, Change from baseline in protein markers in tumor and/or blood. Blood glucose and insulin levels. Tumor response, RECIST defined
Subjects continue on study until disease progression or consent withdrawal
Secondary Endpoints
Metabolic profile in plasma at the maximum tolerated dose
Subjects continue on study until disease progression or consent withdrawal
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK2126458EXPERIMENTALGSK2126458 will be dosed continuously (every day) for the duration a 28 day cycle. The 28 day cycles will continue until the subjects withdraw from the study.
Interventions
NameTypeDescription
GSK2126458DRUGGSK2126458 is an experimental treatment for patients with cancer.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Histologically- or cytologically- confirmed diagnosis of solid tumor malignancy, or lymphoma * Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. * Female or male that is willing to take measures to avoid pregnancy in self or a...

Countries:United StatesNetherlands
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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