Galapagos Starts Phase Ib Clinical Study in Cancer Patients
News Mar 15, 2011
Galapagos NV has announced that it has started a Phase Ib clinical study for GLPG0187, a novel drug being developed for metastatic cancer. In this clinical study, Galapagos plans to assess the safety and explore the preliminary efficacy of GLPG0187 in cancer patients.
"GLPG0187 marks the third Galapagos compound to be tested in patients," said Onno van de Stolpe, CEO of Galapagos. "This compound has already shown potential in the treatment in metastatic cancers in preclinical testing and shown promising biomarker data in healthy volunteers. With this trial we aim to gain the first insight into GLPG0187's antitumor effects in cancer patients."
Details of the Phase Ib clinical trial
The clinical Phase Ib study for GLPG0187 will involve cancer patients with solid tumors. Patients with confirmed diagnosis of advanced, recurrent, or metastatic cancer who are refractory to standard therapy or for whom no standard therapy exists, are eligible to enroll in the trial. They will receive intravenous administration of GLPG0187 for an initial period of four weeks.
The primary endpoint will be to assess the safety and tolerability of GLPG0187 in cancer patients during this four week period.
The secondary endpoints include pharmacokinetics and pharmacodynamics (CTX biomarker) of the candidate drug and preliminary antitumor effects of GLPG0187 according to RECIST 1.1, the standard endpoint for cancer clinical trials.
The number of patients enrolled in this study will depend on the number of dose levels needed to determine the maximum tolerated dose (MTD), which is essential for any cancer therapeutic.
Galapagos has received regulatory approvals to start the study at a first site in Utrecht, The Netherlands. A second center will be added during the course of the trial.