phase II trial


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phase II trial

, phase 2 trial
A clinical trial to determine the potential effectiveness of a new drug. Generally, if at least 20% of the study subjects respond positively to it, e.g., achieve a 50% reduction in the total size of their measurable tumor, the new therapy will receive further testing. Another crucial statistic is the duration of response. Short-term responses may mean little in terms of survival; long-term responses indicate that the drug is benefiting some patients.
See also: trial
References in periodicals archive ?
Complete the Phase II trial in Canada focused on tumor types where anti-cancer activity has been observed, with release of results of this first Phase II study targeted for second half of 2006 at an appropriate scientific venue.
Initiating three single agent trials of ADH-1: a Phase II trial in Canada examining every three week dosing; a Phase Ib/II trial in Europe examining weekly dosing; and a Phase Ib/II trial in the U.
Candidate vaccines that are proven to be safe in Phase I trials move on to Phase II trials, allowing investigators to test the immune response and acquire more data on safety.
As a result, this Phase II trial will be available on an outpatient basis in several cancer centers across the U.
More information about this Phase II trial can be found at http://www.
Osiris made the decision to file for the Phase II trial after discussions with the FDA regarding positive preliminary results.
Osiris is currently enrolling patients in a separate Phase II trial to evaluate this indication.
Phase II trials tend to last only a few weeks to, at most, a few months.
Subsequent Phase II trials (often called, IIb) are aimed at elucidating dose response relationships, safety and, for the first time, efficacy, of the compound treating the disease or condition for which it is intended.
In its joint venture with Genzyme Corporation, Dyax has successfully completed three Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE).
Clinical activity was seen over a range of doses and ZIO-101 has now entered phase II trials.