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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
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.
Four weeks + three-week cycles
Giocondo Lorenzon, MSc
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)