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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
continuous IV infusion
Nationaal Kanker Instituut (NKI)
Amsterdam, Netherlands
Universitair Medisch Centrum
Utrecht, Netherlands
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.
Time frame: Four weeks + three-week cycles
Pharmacokinetics of GLPG0187 after intravenous infusion.
Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to establish the concentration of the study medication in the blood.
Time frame: Up to four weeks.
Pharmacodynamics of GLPG0187
Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to measure the levels of CTx (collagen telopeptide, a bone resorption biomarker).
Time frame: Up to four weeks
Preliminary efficacy of GLPG0187 in terms of clinical activity.
evaluation of antitumor effects according to RECIST 1.1.
Time frame: Four weeks + three-week cycles
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