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 ?
Primary endpoint of the Phase II trial is measurement of the enzyme chitotriosidase, which is a known and well-characterised marker of Gaucher disease.
Vical plans to initiate a single Phase II trial for the treatment of invasive aspergillosis (IA) in acute leukemia patients and allogeneic hematopoietic cell transplant (HCT) recipients in the fourth quarter of 2017.
Linda Powers, CEO of NW Bio, noted that, More than 2 years of planning and work have gone into developing this Phase II trial program.
Genticel, a France-based biotechnology company, has completed patient enrolment in the Phase II trial of its lead therapeutic vaccine candidate, ProCervix, it was reported yesterday.
A Practical Guide to Designing Phase II Trials in Oncology
Early positive signals from the phase II trial prompted Amgen to initiate a phase III randomized, alendronate-controlled trial in more than 5,000 postmenopausal women with osteoporosis to determine whether AMG 785 can prevent fractures.
The current study, together with the previous phase II trials, will pave the way for the pivotal phase III programme, expected to start in 2013, Photocure said.
"Our [Phase I] clinical trial of AMR-001 yielded significant results, forming the basis for the Phase II trial."
The most common adverse event with AMG 785 in the phase II trial was injection site reaction (9.8%).
The Phase II trial follows a successful Phase Ia combination REOLYSIN/radiation trial in which enrollment was completed in June 2006.
The company says the approval followed the successful end of a phase II trial. As part of the end of the phase II trial, the FDA offered its Special Protocol Assessment (SPA) for Reviroc for protocol design of a phase II clinical study.
In one phase II trial, the investigators found that depression scores for patients on lurasidone improved by 2.9 points, compared with 0.1 points for those taking placeba.