Still, as the trial opened in December 2006, Dr. Flaherty insisted on an approach that slowed them down. The companies had stipulated that any cancer patient could participate, a standard practice to speed the process of settling on a safe dose before moving on to a larger, Phase 2 trial.
But in the case of a targeted drug like PLX4032, Dr. Flaherty believed, it made far more sense to give it only to the patients for whom it was made.
Whenever possible, Dr. Flaherty and his co-investigator, Dr. Paul Chapman of Memorial Sloan-Kettering Cancer Center, agreed, they would screen tumors first for the B-RAF mutation, and offer a spot on the trial for those who had it.
I find it amazing that the trial investigators feel that they can add to the protocol in a very substantive way. Of course it is only a ph i - but I would have never guessed that this kind of protocol addition by an individual investigator would be considered acceptable.
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