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GLPG0187

Phase 1

Solid Tumors | Small molecule | Oncology |Lakefront Biotherapeutics|Trials Updated: Jun 11, 2013

GLPG0187 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jun 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

GLPG0187 clinical trials

GLPG0187 · 1 trial · 1 indication

Phase 1 1
NCT01313598GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid TumorsSolid Tumors
COMPLETED20 Analytics
PHASE1COMPLETED
GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors
Solid TumorsUnlock 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.

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 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:Netherlands
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about GLPG0187

What is GLPG0187 used for?

GLPG0187 is an investigational small molecule developed for the treatment of solid tumors. It has been studied in a Phase 1 clinical trial in patients with solid tumors, and it is not approved for any indication. Lakefront Biotherapeutics is developing the drug.

Who is developing GLPG0187?

GLPG0187 is being developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is responsible for the clinical development of the drug, including the completed Phase 1 trial in patients with solid tumors.

What phase is GLPG0187 in?

GLPG0187 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any use.

What clinical trials is GLPG0187 in?

GLPG0187 has been evaluated in one clinical trial: NCT01313598, titled "GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors." This Phase 1 trial enrolled 20 patients in the Netherlands and is now completed.

Is GLPG0187 FDA approved?

No, GLPG0187 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for solid tumors. Approval has not been granted, and further clinical development would be required before any regulatory submission.