Bayer colon cancer drug moves into phase III
pharmafile | May 11, 2010 | News story | Research and Development | Bayer, colorectal cancer, regorafenib
Bayer Schering Pharma will shortly begin phase III tests of its investigational compound regorafenib for patients with metastatic colorectal cancer.
The disease is the second most prevalent cancer worldwide, with over one million cases occurring every year.
Bayer’s head of global development Kemal Malik said: “The initiation of a phase III clinical trial for regorafenib marks the starting point for a potential new treatment option for colorectal cancer patients, and is an important milestone for Bayer in our ongoing effort to meet the unmet needs of people affected by cancer.”
The CORRECT trial is an international, randomised, double-blind, placebo-controlled study and will involved around 700 patients with metastatic colorectal cancer (CRC) who have progressed after standard therapies. They will receive either regorafenib and best supportive care, or placebo and best supportive care.
The primary endpoint of this trial is overall survival; the secondary endpoints include: progression-free survival, objective tumour response rate and disease control rate.
Regorafenib is a potent oral multi-kinase inhibitor that targets angiogenic, stromal and oncogenic tyrosine kinases.
Roche are the current leaders in CRC treatment, with oral drug Xeloda, indicated as a first-line treatment with traditional chemotherapy, and Avastin, also combined with chemotherapy, indicated for either first- or second-line treatment.
Avastin made the oncology specialist CHF 6.2 billion in 2009 with CRC-specific Xeloda CHF 1.3 billion.
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