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Brief Title: A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
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
Study ID: NCT00958477
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Institut Jules Bordet - Medical Oncology Clinic, Brussels, , Belgium
Universit盲tsklinikum Aachen, A脰R - Medizinische Fakult盲t der RWTH - Klinik f眉r Urologie, Aachen, , Germany
Universit盲tsklinikum "Carl Gustav Carus" Dresden - Klinik und Poliklinik f眉r Urologie, Dresden, , Germany
Klinikum Rechts der Isar - Urologische Klinik und Poliklinik, M眉nchen, , Germany
Name: Wolfgang Uhl, Dr, Dipl. Chem., Physician
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR