Date: 2016-10-20
Type of information: Initiation of the trial
phase: 3b
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: LEE011 (ribociclib)
Action
mechanism: kinase inhibitor/cyclin dependent kinase inhibitor. LEE011 (ribociclib) is a selective cyclin dependent kinase inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly. LEE011 has been studied in non-clinical models and is currently being evaluated in combination with additional endocrine agents as part of the MONALEESA (Mammary ONcology Assessment of LEE011's Efficacy and SAfety) clinical trial program. LEE011 was developed by Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals. In August, the FDA has granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
Disease: advanced breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: COMPLEEMENT-1 is an open-label, multicenter, phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease. The purpose of this Phase IIIb study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and postmenopausal women with HR+HER2- advanced breast cancer. (NCT02941926)
Latest
news: * On October 20, 2016, a Phase 3b trial sponsored by Novartis was published on the NIH website ClinicalTrials.gov for LEE011 (ribociclib).
