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GLPG0187

Phase 1

Healthy | Small molecule | Other |Lakefront Biotherapeutics|Last Updated: Jun 11, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

GLPG0187 · 2 trials · 2 indications

Phase 1 2
NCT01313598GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid TumorsSolid Tumors
COMPLETED20 Analytics
NCT00928343First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187Healthy
COMPLETED18 Analytics
PHASE1COMPLETED
GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors
Solid TumorsUnlock trial analytics
PHASE1COMPLETED
First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187
HealthyUnlock trial analytics

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.

Safety and tolerability of single subcutaneous and oral dosing
up to day 10 postdose

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
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GLPG0187DRUGcontinuous IV infusion
PlaceboDRUGMatching subcutaneous or oral placebo
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Eligibility Criteria

Age Range18 Years to 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:NetherlandsBelgium
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