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

Background 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 intrav...

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Bibliographic Details
Published in:Cancer 2023-01, Vol.129 (1), p.39-48
Main Authors: Doersch, Karen M., Tabayoyong, William B., Bandari, Jathin
Format: Article
Language:English
Subjects:
Administration, Intravesical
Adverse events
Bladder
Bladder cancer
Cancer
Clinical trials
Constraining
Design optimization
dose‐limiting toxicity
Drug development
Drug dosages
Drugs
Heterogeneity
Humans
Intravenous administration
intravesical chemotherapy
Oncology
Pharmaceutical Preparations
phase 1 clinical trial
serious adverse events
severe adverse events
Toxicity
Urinary Bladder Neoplasms - drug therapy
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Summary:Background 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. Methods Studies were ed from ClinicalTrials.gov and reconciled with a PubMed search. Primary and secondary end points were predefined before data ion, and the primary end point was subject–level dose‐limiting toxicity rate. Fisher exact tests were performed with p 
ISSN:0008-543X
1097-0142
DOI:10.1002/cncr.34508