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Spots Global Cancer Trial Database for A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer

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Trial Identification

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

Interventions

EMD 525797

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Wolfgang Uhl, Dr, Dipl. Chem., Physician

Affiliation: Merck KGaA, Darmstadt, Germany

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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