Date: 2011-03-14
Type of information:
phase: 1b
Announcement: initiation
Company: Galapagos (Belgium)
Product: GLPG0187
Action
mechanism: GLPG0187 is an integrin receptor antagonist (IRA). It binds to six integrin receptors known to be present in many metastatic cancers, affording a unique anti-integrin profile. In animal studies, oral administration of GLPG0187 as a single agent has been shown to inhibit multiple processes involved in the spread and growth of metastatic tumors. A Phase I clinical study for GLPG0187 in healthy volunteers showed good safety and a promising biomarker profile.
Disease: metastatic cancer
Therapeutic area: Cancer - Oncology
Country: The Netherlands
Trial
details: 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 (Response Evaluation Criteria In Solid Tumors), 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.
Latest news: Galapagos 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. 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.
