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Evaluation of toxicities for intravesical drugs in phase 1 bladder cancer trials

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Improving clinical trial design is important for optimizing approval of safe and effective drugs. Phase 1 clinical trials seek to determine phase 2 doses by investigating predefined dose‐limiting toxicities. Traditional… Click to show full abstract

Improving clinical trial design is important for optimizing approval of safe and effective drugs. Phase 1 clinical trials seek to determine phase 2 doses by investigating predefined dose‐limiting toxicities. Traditional definitions of dose‐limiting toxicity may not be applicable to intravesical therapies for bladder cancer. This study compared the frequency of dose‐limiting toxicities and serious adverse events in bladder cancer trials for intravesical therapies to other routes of administration.

Keywords: cancer trials; bladder cancer; cancer; drugs phase

Journal Title: Cancer
Year Published: 2022

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