Phase 1: Finding the right dose

Phase 1: The first step in testing promising new treatments in people.

The goals of a Phase 1 treatment clinical trial are to find:

  • The safest dose of treatment
  • Information about side effects
  • How the dose should be given and how often
  • How the treatment is processed in the body
  • How the treatment is affecting the cancer

Phase 1 clinical trials are not always specific to one type of cancer. They usually involve only a small number of patients, about 20 to 80, at a few cancer centres and may be offered when there is no standard treatment available. Only 3 to 4 patients are allowed to join the clinical trial at a time; this is called a cohort. The progress of each cohort is evaluated before another cohort can join the trial. Each cohort may be given treatment at a different dose level based on these evaluations to make sure the safest, maximum tolerated dose is given. Once this dose is found, the treatment will proceed to Phase 2 testing.

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