Date: 2015-04-14
Type of information: Initiation of the trial
phase: 2,3
Announcement: initiation of the trial
Company: Bayer Healthcare (Germany)
Product: BAY 80-6946 - copanlisib
Action
mechanism: kinase inhibitor/phosphoinositide 3-kinase (PI3K) inhibitor. Copanlisib is an intravenous small molecule inhibitor of the phosphatidylinositol 3-kinase (PI3K) with predominant inhibitory activity against both PI3K-δ and PI3K-α isoforms. The PI3K pathway is one of the most frequently altered pathways in cancer and the PI3K isoforms regulate many cellular functions, such as growth control, metabolism and transcription initiation. Copanlisib was recently granted Orphan Drug Designation by the FDA in the U.S. for the treatment of follicular lymphoma (FL), a histologic subtype of NHL.
Disease: diffuse large B-cell lymphoma (DLBCL)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On April 14, 2015, Bayer HealthCare announced the expansion of its global clinical development program for the investigational oncology compound copanlisib (BAY 80-6946), which now includes two new Phase III studies and one additional Phase II study exploring new treatment options for various subtypes of non-Hodgkin’s lymphoma (NHL). Three new studies will open for enrollment by mid 2015 to investigate the efficacy and safety of copanlisib in patients with recurrent indolent NHL and diffuse large B-cell lymphoma (DLBCL), an aggressive subtype of NHL. The expanded clinical program will now include: • CHRONOS-2: A Phase III randomized, double-blind, placebo-controlled study of copanlisib in rituximab refractory indolent NHL patients who have previously been treated with rituximab and alkylating agents (NCT02369016), • CHRONOS-3: A Phase III randomized, double-blind study evaluating the efficacy and safety of copanlisib in combination with rituximab versus rituximab monotherapy in patients with relapsed indolent NHL who have received at least one prior line of treatment, including rituximab and an alkylating agent (NCT02367040), • A Phase II open-label, single-arm study in patients with relapsed or refractory DLBCL to evaluate the efficacy and safety of copanlisib and assess the relationship between efficacy and potentially predictive biomarkers (NCT02391116). The new studies add to the ongoing clinical development program for copanlisib, including several Phase I/Ib studies as well as an open-label Phase II trial evaluating the efficacy and safety in patients with relapsed or refractory NHL (NCT01660451). This Phase II study consists of two parts, with Part A in indolent and aggressive forms of NHL. Results of Part A of this Phase II study were presented at the the 57th Annual Meeting of the American Society of Hematology (ASH) in December 2014. Part B is an extension of the Phase II study investigating copanlisib in indolent forms of NHL and is currently ongoing (CHRONOS-1).
