GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and tolerability [ Time Frame: Four weeks + three-week cycles ] [ Designated as safety issue: Yes ]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.
- Pharmacokinetics of GLPG0187 after intravenous infusion. [ Time Frame: Up to four weeks. ] [ Designated as safety issue: No ]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.
- Pharmacodynamics of GLPG0187 [ Time Frame: Up to four weeks ] [ Designated as safety issue: No ]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).
- Preliminary efficacy of GLPG0187 in terms of clinical activity. [ Time Frame: Four weeks + three-week cycles ] [ Designated as safety issue: No ]evaluation of antitumor effects according to RECIST 1.1.
|Study Start Date:||March 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
GLPG0187 for infusion
continuous IV infusion
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.
|Nationaal Kanker Instituut (NKI)|
|Amsterdam, Netherlands, 1066 CX|
|Universitair Medisch Centrum|
|Utrecht, Netherlands, 3584 CX|
|Study Director:||Giocondo Lorenzon, MSc||Galapagos SASU|