It failed to meet its primary endpoint, but subgroup analysis suggested that it might improve or stabilize disease activity in some patients [ 22].
Roche said in a statement that it did not meet its primary objective of extending overall survival compared with chemotherapy and prednisone alone, and a preliminary safety assessment showed adverse events that had been previously observed in Avastin trials.
Vatalanib failed to enter clinical practice because it did not meet its primary end point of OS despite demonstration of PFS benefit.
Preliminary results of the trial reveal that it failed to meet its primary endpoint over the 24 week period, potentially suggesting that the TRACTISS trial is justified in assessing the efficacy of two courses of treatment, each with two doses, spaced two weeks apart which is in contrast to the French trial which administered only one course of two doses.
Remune's manufacturer, the Immune Response Corporation of Carlsbad, Calif., stopped a full-scale trial involving more than 2,500 infected volunteers last year because a monitoring committee deemed it unlikely to provide statistically significant findings to meet its primary objective, which was to measure disease progression to an AIDS-related condition, or death.
It is a necessary step to allow such testing to meet its primary goals in a timely and cost-effective way.
However, recently it was announced that this Phase 2b CUPID2 trial did not meet its primary and secondary endpoints (http://ir.celladon.com/releasedetail.cfm?releaseid=908592).
The results were considered positive, even though the study of 240 patients with Alzheimer's did not meet its primary goals.
Dr Harvey White said: While the study didn't meet its primary endpoint, the effects of darapladib on the reduction of coronary events are of potential interest.
The lawsuit, filed last year, will have its first major hearing in federal District Court in Denver on Feb. 15. "A legislature unable to raise and appropriate funds cannot meet its primary constitutional obligations," the Colorado lawsuit reads.
Although the trend in overall survival was encouraging, the study failed to meet its primary endpoint.
