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TSR-011

Phase 1

Solid Tumors | Small molecule | Oncology |GSK plc|Last Updated: Mar 26, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02048488A Phase I/IIa Open-Label, Dose Escalation and Cohort Expansion Trial of Oral TSR-011 in Patients With Advanced Solid Tumors and LymphomasPHASE1 COMPLETED 72Oct 1, 2012Jun 1, 2018Mar 26, 201915 United States, Poland +3
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
Approximately 2 years
Secondary Endpoints
Area Under the Concentration-Time Curve (AUC)
Day 1: 0-24 hrs after first dose; pre-dose on days 8 & 15; day 29: 0-24 hours
Maximum Tolerated Dose (MTD)
28 days after first dose
Response Rate (RR)
approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental Drug TSR-011EXPERIMENTALExperimental Drug TSR-011
Interventions
NameTypeDescription
TSR-011DRUGNumber of cycles until progression or unacceptable toxicity develops.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * To be considered eligible to participate in this study, all of the following requirements must be met: 1. Patients in Phase 1 must have metastatic or locally advanced solid tumors who have failed to respond to standard therapy 2. All patients must have confirmation of eit...

Countries:United StatesPolandSpainTaiwanUnited Kingdom
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