New options for late stage CC, possibly. Early access trial.

Regorafenib Now Available Via Expanded Access
Posted by Kate Murphy on April 30th, 2012

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The first four sites where colorectal cancer patients can get regorafenib are now open. Bayer Healthcare expects to open additional sites in the next two or three weeks.

Colorectal cancer patients whose cancer has gotten worse on all standard treatments can now be considered for the Regorafenib Extended Access program.

Bayer Healthcare has applied for FDA approval of regorafenib to treat colorectal cancer, but until it is actually approved and on the market, the expanded access program is the only way patients who might benefit can receive it.

Last fall, early results from the randomized Phase 3 CORRECT clinical trial showed colorectal cancer patients who received regorafenib lived longer than a similar group who got a placebo.
Results of the CORRECT trial were discussed at the 2012 GI Cancers Symposium in January. Axel Grothey, MD and his team concluded,

Statistically significant benefit in overall survival and progression-free survival was observed for regorafenib over placebo in patients with metastatic colorectal cancer who have failed all approved standard therapies. No new or unexpected safety signal was found.

Patients in the expanded access program will get regorafenib pills every day for three weeks, followed by a week’s rest before repeating the treatment cycle.

The first sites are now open in:

■Sumter, SC
■Charleston, SC
■Jefferson City, MO
■Aventura, FL
For additional information email clinical-trials-contact@bayerhealthcare.com