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'Phase 0' Trials Aim to Speed Cancer Drug Development
Date:4/17/2009

percent of new oncology drug applications submitted to the U.S. Food and Drug Administration get approved, according to the National Cancer Institute. One reason is the lack of systems to predict early on which drugs would be useful and which would have too many side effects, Doroshow explained. In fact, 70 percent of phase II drugs don't make it to the third phase because of a lack of efficacy.

"We need to have a better handle on whether or not they are going to be useful sooner," he added.

To speed up development, the National Cancer Institute established the NCI Experimental Therapeutics (NExT) program, of which phase 0 trials are an integral part.

The first-ever phase 0 trial involved ABT-888, an oral drug that inhibits an enzyme critical for repairing DNA damage. It's believed that the drug could improve the effectiveness of chemotherapy. Researchers obtained key data within five months of the study's initiation, which helped guide the design of subsequent phase I trials. The findings were published online April 13 in the Journal of Clinical Oncology.

"I think it's going to lay out a very interesting model for other researchers who are also interested in phase 0 studies," said T. Patrick Hill, senior policy fellow at the Edward J. Bloustein School of Planning and Public Policy at Rutgers, and a clinical research ethics consultant at the Cancer Institute of New Jersey, both in New Brunswick.

Experts expect the model to be used for other types of drugs as well.

Phase 0 trials expose people to less toxicity and involve fewer participants -- 10 to 12, on average, versus 20 to 25 in a phase I trial. Trial participants receive only a limited number of doses -- and much lower doses -- over a shorter period of time. However, because small doses of a drug are given for a short period, participants probably will not realize a therapeutic benefit.

So why participate?

"Altruism is an
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