Date: 2012-04-04
Type of information: Initiation of the trial
phase: 2-3
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: buparlisib (BKM120)
Action
mechanism: phosphoinositide 3-kinase (PI3K) inhibitor. Buparlisib is an orally bioavailable specific oral inhibitor of the pan-class I phosphatidylinositol 3-kinase (PI3K) family of lipid kinases. It specifically inhibits class I PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway in an ATP-competitive manner, thereby inhibiting activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Republic of Korea, The Netherlands, Russian Federation, Singapore, South Africa, Spain, Taiwan, UK, USA
Trial
details: This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.(NCT01572727 )
Latest
news: * On April 4, 2012, the BELLE-4 Phase 2-3 trial sponsored by Novartis was published on the NIH website ClinicalTrials.gov for buparlisib and the study has now been completed.
