Phase II study of @entity46822 in the treatment of advanced androgen-independent XXXX .

@entity1 @entity137 @entity263 @entity2741 @entity46822 @entity2629 @entity1142 @entity1486 @entity560
PURPOSE: In this single institution Phase II trial, we evaluated the efficacy of the @entity560 analogue, @entity46822 , in @entity1 with advanced @entity263 . EXPERIMENTAL DESIGN: The @entity1 initially received @entity46822 at 12.5 micro g p.o. every day, which was dose adjusted for @entity2741 . Given the cytostatic nature of the drug, the primary study end point was progression-free survival for a minimum of 6 months. The secondary end point was further characterization of @entity137 . RESULTS: A total of 26 @entity1 was enrolled. Using the intent-to-treat population, stable disease was seen for an average of 19.2 weeks (median 12 weeks, range 3-108 weeks). Twenty @entity1 were evaluable for response. The one @entity1 that achieved disease stabilization for >2 years elected to come off-study because of @entity1 preference. His last disease evaluation showed no evidence of progression. No objective responses were seen. Previous and ongoing clinical observations strongly imply that @entity1486 could be a misleading surrogate marker for clinical effect with this type of drug. Therefore, @entity1486 was not used as a marker for disease response. @entity137 was as expected with mild @entity2741 and associated symptoms like @entity1142 and @entity2629 seen in some @entity1 . Six (30%) evaluable @entity1 experienced stable disease for >6 months, suggesting possible cytostatic activity. CONCLUSION: The results of this and other trials suggest further clinical investigation in this disease with @entity560 analogues alone or in combination with other agents, such as chemotherapy, should be pursued.
