Date: 2013-05-15
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of patient enrollment
Company: Bayer Healthcare (Germany)
Product: regorafenib (BAY 73-4506)
Action
mechanism: multi-kinase inhibitor.Regorafenib is an oral multi-kinase inhibitor with a distinct profile targeting angiogenic (VEGFR, TIE-2), stromal (PDGFR) and oncogenic (RAF, RET and KIT) receptor tyrosine kinases
Disease: hepatocellular carcinoma (HCC)
Therapeutic area: Cancer - Oncology
Country: North America, South America, Europe, Asia and Australia
Trial
details: The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial is a randomized, double blind, placebo controlled, multicenter Phase III study of regorafenib in patients with hepatocellular carcinoma whose disease has progressed after treatment with sorafenib.Approximately 530 patients who meet the entry criteria will be randomly assigned in a 2:1 ratio to regorafenib or placebo (1/3 chance to receive placebo).Patients will receive 160 mg regorafenib once daily, for 3 weeks on/1week off, or placebo. The primary endpoint of the study is overall survival, and secondary endpoints are time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability of the treatment groups will also be continously monitored. (NCT01774344)
Latest
news: * On May 15, 2013, Bayer HealthCare has announced that the company has started to enroll patients in an international Phase III trial to evaluate the efficacy and safety of regorafenib for the treatment of patients with hepatocellular carcinoma (HCC) who have progressed on sorafenib treatment. The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial will enroll approximatehly 530 patients who will be randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Regorafenib was approved under the name Stivarga® by the FDA for the treatment of metastatic colorectal cancer (mCRC) in September 2012 and for the treatment of gastrointestinal stromal tumors (GIST) in February 2013. It was also approved in Japan for the treatment of advanced or recurrent CRC in March 2013. Bayer has also submitted for marketing approval of regorafenib for the treatment of mCRC in the EU in May 2012. In December 2012, Bayer submitted a filing in Japan for regorafenib for the treatment of GIST and has received priority review for this indication. Regorafenib is developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
