CPHON Review questions with correct answers

Phase 1 Trial - Answer Determines the maximum tolerated dose of an investigational agent or combination of agents that is then recommended for use Patients must have adequate organ function, reasonable life expectancy and ability to function. And all standard therapeutic options for curative treatments must have been exhausted Phase 2 Trial - Answer Designed to determine the efficacy of a new agent in treating specific types of cancer All patients must have measurable disease, normal organ function, reasonable life expectancy and a reasonable functional status Phase 3 Trial - Answer Used to assess the overall response, survival and quality of life of newly diagnosed patients with a specific diagnosis within the new treatment plan Goal is to determine whether the treatment is equivalent or superior to the current or standard treatment Phase 4 Trial - Answer Meant to further investigate the long term safety and efficacy of a treatment and takes place after the new treatment is approved for standard use Their goal is to decrease side effects, toxicities, and late effects of treatment while continuing to produce acceptable cure rates