Date: 2013-09-10
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Exelixis (USA - CA)
Product: cabozantinib
Action
mechanism: tyrosine kinase inhibitor. Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of medullary cancer cells. Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and AXL. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Disease: advanced hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Canada, France, Germany, Hong Kong, Ireland, Italy, Republic of Korea, The Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Taiwan, Turkey, UK, USA, Brazil, Georgia, Mexico
Trial
details: CELESTIAL is a randomized, double blind, placebo controlled study of cabozantinib in patients with advanced hepatocellular carcinoma that is being conducted at up to 200 sites globally in up to 30 countries. The trial is expected to enroll 760 patients with advanced hepatocellular carcinoma who have received prior sorafenib. Patients will be randomized 2:1 to receive 60 mg of cabozantinib daily or placebo. (NCT01908426)
Latest
news: * On September 10, 2013, Exelixis announced that it has initiated CELESTIAL, a phase 3 pivotal trial comparing cabozantinib with placebo in patients with advanced hepatocellular carcinoma who have previously been treated with sorafenib. The primary endpoint for the trial is overall survival (OS), and the secondary endpoints include objective response rate (ORR) and progression-free survival (PFS). Exploratory endpoints include patient-reported outcomes, biomarkers, and safety. Based on available clinical trial data, the primary endpoint assumes a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90% power to detect a 32% increase in OS (HR = 0.76). Interim analyses are planned once 50% and 75% of events have been observed, respectively.
