Date: 2015-05-23
Type of information: Initiation of the trial
phase: 2
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-? and PI3K-? 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: mantle cell lymphoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib. (NCT01777152)
Latest
news: * On May 23, 2015, a Phase 2 trial sponsored by Bayer was published on the NIH website ClinicalTrials.gov for copanlisib and is currently recruiting participants. ("A single-arm, open-label Phase IIa study to evaluate the efficacy and safety of copanlisib monotherapy in patients with relapsed or refractory mantle cell lymphoma (MCL), who failed ibrutinib treatment or were unable to tolerate ibrutinib"). It is anticipated that the trial will end in August 2019.
