The primary objective of this study is to evaluate the safety and toxicity profile of LY300502 administered at four different doses and to measure the reduction in serum DHT levels from baseline in patients treated at these doses to define the maximum biological effect (MBE) dose. This is a non-randomized dose finding study of LY300502 in patients with metastatic prostate cancer who have failed or are not candidates for convention hormonal therapy. LY300502 will be administered three times daily for a period of 12 weeks. In order to define the dose at which DHT suppression is maximized with acceptable safety and pharmacokinetic profiles, patients will be entered in four cohorts of 8 patients each.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000056-38S3
Application #
6219279
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
1999
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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