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Tag Archives: phase 0

Abbott’s ABT-888 Guinea Pig: First Phase 0 Clinical Trial Completed

A press release from the National Cancer Institute yesterday (picked up today by BIO SmartBrief and FierceBiotech) touts a successful first:

The first phase 0 clinical trial of a drug in cancer treatment, involving 13 patients with advanced cancers, showed that the drug, ABT-888, affected its target and was well tolerated. Most importantly, this trial showed that it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly.

The point of a “phase 0″ (phase zero) trial is to focus “primarily on tolerance and the ability of the drug to hit a target.”  The advantage of phase 0 trials is that they:

involve nontoxic drug doses that are administered for short periods of time to small numbers of patients, [so] the preclinical toxicology data required … are less than those required to support a phase I trial; thus, these first-in-human trials can be initiated earlier in the drug development process than traditional phase I studies.

Phase 0 trials come with their own statistical evaluation scheme and endpoints, and although more long-term data is needed on the impact of this approach on timetables and success rates, “phase 0 trials will be a key part of a new approach” in the NCI Experimental Therapeutics (NExT) program.

Here’s NCI’s FAQ from the 2007 introduction of the program, with more info on NExT and phase 0 trials.

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