Multicentric Parallel Phase II Trial of the Polo-Like Kinase 1 Inhibitor BI 2536 in Patients With Advanced Head and Neck Cancer, Breast Cancer, Ovarian Cancer, Soft Tissue Sarcoma, and Melanoma. The First Protocol of the European Organization for Research and Treatment of Cancer Network of Core Institutes

In a multicentric parallel phase II trial conducted 13 years ago, the polo-like kinase 1 inhibitor BI 2536 was tested on 76 patients with advanced head and neck, breast and ovarian cancer, soft tissue sarcoma, and melanoma. The patients received a median number of two cycles of BI 2536 200-250 mg intravenously every 3 weeks. The most common grade 3-4 adverse events were neutropenia (81.6%), thrombocytopenia (19.7%), febrile neutropenia (19.7%), anemia (15.5%), and pain (9.9%). The study found no confirmed objective responses, leading to the conclusion that BI 2536 showed limited antitumor activity in the five different tumor types tested. Derivatives of BI 2536 with a more favorable pharmacological profile were being explored in prospective studies at the time.