Regorafenib available in expanded access program for colon cancer

Bayer, the maker of an experimental drug for colorectal cancer and GIST, has opened an expanded access program for colorectal cancer patients who have progressed on other therapies.Patients are encouraged to talk to their doctor about whether they are eligible for the program.Details can be found at: Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy: CONSIGNRegorafenib is a targeted agent that has shown slight progression-free survival benefit in patients who have progressed on several lines of therapy. Results from the CORRECT trial, which was first presented at the ASCO Gastrointestinal Symposium earlier this year, showed that the drug improved survival by a median of 1.4 months, from 5 months with placebo to 6.4 months--a 29 percent increase in overall survival. The drug controlled the disease in nearly half of patients, delaying or reducing tumor growth in 44.8 percent of patients as opposed to 15.3 percent in the placebo arm. The phase 3B expanded access program was designed to provide patients with metastatic colorectal cancer the drug if they have no other therapy options. The program will be until the drug is approved, which is not guaranteed. Researchers will be collecting safety data during the study. Common side effects reported included hand-foot rash, fatigue and diarrhea.Patients will take the oral drug once a day in four-week cycles (daily for three weeks, then one week off before starting therapy again.) More information on expanded access and other programs to access investigational therapies can be found in "Ethics of Access." You can also find more information on the FDA.gov website.Bayer has opened 55 sites around the world, including at least 10 sites in the U.S. For more information on access to regorafenib, email Bayer at clinical-trials-contact@bayerhealthcare.com.