Phase I trials
From Standard of Care
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Clinical trials for anticancer trials are the first step in testing new therapies, establishing safe drug doses and looking for the first indication of clinical activity.
Include first human studies as well as studies that combine 2 or more experimental drugs or approved drugs for the first time.
Objectives to evaluate safety, pharmokinetic properties, and pharmacodynamic aspects of agents and to establish optimal doses for further trials.
In oncologic studies they are utilized to describe initial antitumor response and to gain information about the effect of a targeted agent on its target.
Designed to identify dose levels of novel drugs or combinations of agents for further evaluations in phase II trials.
Clinical benefits may be limited and patients considered for such studies usually have advanced cancer for which there is no standard treatment.
Study entry requirements usually include reasonable level of performance, organ function an expected life expectancy of greater than 3 months.
Approximately 15-20% of participants die within the first 90 days of entry to study.