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

Report on first such study involves effort to improve chemotherapy effectiveness

FRIDAY, April 17 (HealthDay News) -- Even after years of painstaking research and testing, only a small percentage of cancer agents make it from the laboratory to the patient. So scientists have come up with a way to weed out the duds earlier in the process and speed good medications to the marketplace.

The new model, a so-called "phase 0" clinical trial, promises to streamline the costly and time-consuming drug development process, helping to deliver good drugs to people who need them more quickly.

"We want to find out if they're ineffective in the smallest number of patients and get definitive information as early in the development process as possible," said Dr. James H. Doroshow, director of the division of cancer treatment and diagnosis at the National Cancer Institute in Bethesda, Md.

As the name implies, a phase 0 trial precedes "phase I" testing, traditionally the first step in the process of human drug testing. In a phase I study, the goal is to determine the best way to administer a drug and the maximum dose tolerated with the fewest side effects.

Phase 0 studies expose a small number of people to low doses of a drug over a limited period of time -- seven days or less. Scientists look at how the body reacts to the drug and how it acts in the body. If the drug hits its intended target without producing significant side effects, the next phase can be expedited. If not, a decision can be made to scrap the drug before it goes on to further, more costly development and testing.

"It may help accelerate clinical drug development in oncology because you're able to theoretically get the drug into man faster and learn more about the drug in man earlier," explained Dr. Patricia M. LoRusso, director of the phase I clinical-pharmacology team at the Barbara Ann Karmanos Cancer Institute in Detroit.

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