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GLPG0187

Phase 1

Solid Tumors | Small molecule | Oncology |Galapagos NV|Last Updated: Jun 11, 2013

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01313598GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid TumorsPHASE1 COMPLETED 20Mar 1, 2011Jun 1, 2013Jun 11, 20132 Netherlands
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Study Endpoints
Primary Endpoints
Safety and tolerability
Four weeks + three-week cycles

Patients will be monitored for cardiovascular safety (ECG) and adverse events, and blood- and urine-samples taken before and at fixed timepoints after a one-hour infusion of GLPG0187; if patients tolerate the treatment well, procedures will be repeated before and at fixed timepoints after the start of a three-week continuous infusion patients. Through monitoring and analysis of the blood- and urine-samples, it will be established whether the study medication would have any negative effects on the patient's general condition. Results will indicate whether DLT has occurred.

Secondary Endpoints
Pharmacokinetics of GLPG0187 after intravenous infusion.
Up to four weeks.
Pharmacodynamics of GLPG0187
Up to four weeks
Preliminary efficacy of GLPG0187 in terms of clinical activity.
Four weeks + three-week cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLPG0187EXPERIMENTALGLPG0187 for infusion
Interventions
NameTypeDescription
GLPG0187DRUGcontinuous IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer who are refractory to standard therapy or for whom no standard therapy exist. * Age of 18 years or older. * Measurable (according to RECIST 1.1) and evaluable disease as determined by the Investiga...

Countries:Netherlands
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