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GSK923295

Phase 1

Cancer | Small molecule | Oncology |GSK plc|Last Updated: Jul 12, 2018

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 Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00504790Phase I Study to Assess the Safety, Pharmacokinetics, & Pharmacodynamics of GSK923295 in Subjects w/ Refractory CancerPHASE1 COMPLETED 39Jun 25, 2007May 8, 2012Jul 12, 20183 United States
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Study Endpoints
Primary Endpoints
Safety: - physical exam
at screen & Day(D) 1 of each cycle and follow-up(F/U)
- vital signs and lab tests
at screen & D1, 8, 15, & 22 for each cycle & F/U
- ECGs
at screen and D1, 8 & 15 for each cycle & F/U
continuous monitoring of adverse events
each visit
Secondary Endpoints
Plasma samples of GSK923295 taken at:
- Day 1 & 15 (Cycle 1) for Stage 1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK923295EXPERIMENTALanti-mitotic compound under study
Interventions
NameTypeDescription
GSK923295DRUGanti-mitotic compound
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Signed, written informed consent provided. * a) Stage 1 Subjects: Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to accepted standard therapies, or for which there is no standard therapy. b) Stage 2 Subjects: Histologica...

Countries:United States
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