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The basket trial refers to a new type of phase II cancer trial that evaluates the therapeutic effect of a targeted agent simultaneously in patients with different types of cancer that involve the same genetic or molecular aberration. Although patients who are enrolled in the basket trial have the same molecular aberration, it is common for the targeted agent to be effective for patients with some...
In the early phase development of molecularly targeted agents (MTAs), a commonly encountered situation is that the MTA is expected to be more effective for a certain biomarker subgroup, say marker‐positive patients, but there is no adequate evidence to show that the MTA does not work for the other subgroup, that is, marker‐negative patients. After establishing that marker‐positive patients benefit...
Accumulating evidence shows that the conventional one‐size‐fits‐all dose‐finding paradigm is problematic when applied to different ethnic populations. Because of inter‐ethnic heterogeneity, the dosage established in a landmark trial for a certain population may not be generalizable to a different ethnic population, and a follow‐up bridge trial is often needed to find the maximum tolerated dose for...
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