Single arm two-stage studies: Improved designs for molecularly targeted agents
نویسندگان
چکیده
منابع مشابه
Optimal two-stage designs for single-arm phase II oncology trials with two binary endpoints.
OBJECTIVES In phase II clinical trials in oncology, the potential efficacy of a new treatment regimen is assessed in terms of anticancer activity. The standard approach consists of a single-arm two-stage design where a single binary endpoint is compared to a specified target value. However, a new drug would still be considered promising if it showed a lower tumor response rate than the target l...
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Cardiac toxicity of molecularly targeted cancer agents is increasingly recognized as a significant side effect of chemotherapy. These new potent therapies may not only affect the survival of cancer cells, but have the potential to adversely impact normal cardiac and vascular function. Unraveling the mechanisms by which these therapies affect the heart and vasculature is crucial for improving dr...
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Background Traditionally, the purpose of a dose-finding design in cancer is to find the maximum tolerated dose based solely on toxicity. However, for molecularly targeted agents, little toxicity may arise within the therapeutic dose range and the dose-response curves may not be monotonic. This challenges the principle that more is better, which is widely accepted for conventional chemotherapy. ...
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Phase I oncology trials are designed to identify a safe dose with an acceptable toxicity profile. In traditional phase I dose-finding design, the dose is typically determined based on the probability of severe toxicity observed during the first treatment cycle. The recent development of molecularly targeted agents and cancer immunotherapies call for new innovations in phase I designs, because o...
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Molecularly targeted agent (MTA) combination therapy is in the early stages of development. When using a fixed dose of one agent in combinations of MTAs, toxicity and efficacy do not necessarily increase with an increasing dose of the other agent. Thus, in dose-finding trials for combinations of MTAs, interest may lie in identifying the optimal biological dose combinations (OBDCs), defined as t...
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ژورنال
عنوان ژورنال: Pharmaceutical Statistics
سال: 2018
ISSN: 1539-1604
DOI: 10.1002/pst.1896