Clinical trials

The primary aim of the Phase I trials is to establish the safety and tolerability of the compound being tested and to define an optimum dose and schedule for further (Phase II) studies. Other, secondary objectives may be to investigate the pharmacokinetics of the drug in humans and study the efficacy of the drug in the patients.

Because of the toxicity of anti-cancer agents, Phase I trials of these compounds are generally performed in cancer patients and not healthy volunteers. Moreover, unless the drug is designed to treat a particular type of cancer, patients with advanced cancer of any type may be treated in Phase I trials. These patients will often be those who have already received, and their disease progressed through, the standard treatments for their particular condition.

Patients entering all trials must be fully informed about the study and give their consent to participating. The details of the treatment, the patients to be entered, the doses, and the measurements to be made should all be detailed in the protocol that must be approved by the hospital ethics committee before the trial can begin.

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