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SB-715992

Phase 1

Solid Tumor Cancer | Small molecule | Oncology |GSK plc|Last Updated: Oct 16, 2008

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
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00169520SB-715992 In Combination With Docetaxel In Patients With Solid TumorsPHASE1 COMPLETED 30Jun 1, 2004 -Oct 16, 20082 United Kingdom
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Study Endpoints
Primary Endpoints
Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where 1 of 6 (or 17%) subjects experience a dose-limiting toxicity.
throughout the study
Secondary Endpoints
PK endpoints of SB-715992 and docetaxel pending the conduct of the PK interaction portion. Antitumor activity will be assessed every 2 cycles (PD).
every 2 cycles
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
docetaxelDRUG -
SB-715992DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy. * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2. Exclusion criteria: * Fema...

Countries:United Kingdom
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