Prostate Cancer Clinical Trial
Official title:
Phase I, Open-label Study to Investigate Safety, Tolerability, PK, and PD of EMD 525797 After Single and Repeated Dosing at Different Dose Levels in Subjects With Hormone-resistant Prostate Cancer With Bone Mets and Progressive Disease Following Prior CTX
This study is intended to test an experimental new drug called, EMD 525797 (Study Drug).
This drug is not yet approved for sale and has only been tested in a small number of people
to date (prior to this study starting another research study was carried out involving 37
healthy volunteers receiving the Study Drug). Until more is known about this Study Drug, it
can only be used in research studies.
This research study is planned to answer important questions about how the Study Drug is
tolerated and how it may work in patients with prostate cancer with bone metastases.
This is a small study which is expected to include 24 patients, and will be conducted in
approximately 3 hospitals in Germany and 1 hospital in Brussels, Belgium. The study will
last until the last patient has had their last study visit which is expected to be about 18
months in total.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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