phase I clinical trials: changing paradym

jenrio

Many patients won't consider phase I trial to start with.    With trials of more targetted medicine, this may change.

Quoted:Wheler is currently lead investigator for a trial at MD Anderson (similar to Bolero-2, which was a Phase III trial for advanced breast cancer patients) that has enrolled over 100 cancer patients to test Anistrozole (Arimadex®), an anti-hormone therapy agent, in combination with Everolimus (Afinitor®), a therapy targeted to cellular growth. In this particular study, if a patient develops resistance to either of the two drugs, then the strategy is to add a third drug to try and overcome the resistance. This means that treatment in this Phase I trial is truly tailored to both a patient's tumor biology and her response to therapy.

Pam Munster, MD
"Many patients will never consider a Phase I trial because they believe the drug being tested will be in such an early stage of its development that they will not benefit from taking it," says Pam Munster, MD, Director, Early Phase Clinical Trials Unit and Leader, Developmental Therapeutics Program, at the UCSF Helen Diller Family Comprehensive Cancer Center. "But we really try to make every effort to select the right drugs for patients, so they at least have a chance of a good response."

http://breastcancertrials.wordpress.com/2012/05/16/phase-i-clinical-trials-a-changing-paradigm/