NCT01313598

GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors

An Open-label, Dose Escalating Phase Ib Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Intravenous Doses of GLPG0187 in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and tolerability of GLPG0187 administered through continuous intravenous infusion and to explore its preliminary clinical efficacy in patients with solid tumors.

Detailed description

Patients with pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer and who are refractory to standard therapy or for whom no standard therapy exists will first receive a one-hour infusion of a defined dose of GLPG0187. If well tolerated, one week later a three-week continuous infusion is started. If according to the investigator a subject has a clinical benefit from treatment with GLPG0187, the treatment cycle may be repeated until disease progression, Dose Limiting Toxicity (DLT), or the patient chooses to stop or cannot/will not comply with study procedures. Throughout treatment, safety and tolerability will be monitored. Within one patient, a fixed dose (infusion rate) will be used. If at a given dose-level sufficient patients have been treated without reaching DLT, the dose for the next group of patients will be increased. This can be repeated until DLT is established, or the scheduled maximum dosage is reached.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	GLPG0187	continuous IV infusion

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2011-03-14
• Last updated: 2013-06-11

Locations

2 sites across 1 country: Netherlands