A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The incidence of dose limiting toxicity during the first 6 weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Total number of adverse events and total number of serious adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- PD Serum levels of anti-EMD 525797 antibodies to characterize the immunogenic potential [ Time Frame: Up to week 7 ] [ Designated as safety issue: No ]
- PD IL8/6 [ Time Frame: Up to week 7 ] [ Designated as safety issue: No ]
- PD C-Reactive [ Time Frame: Up to week 7 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Biological: EMD 525797
EMD 525797 will be administered as an i.v. over 1 hour every two weeks for 6 weeks. Subjects with clinical benefit at end of week 6 will be offered continuation of treatment with EMD 525797 at the same dose-level until disease progression, intolerance to treatment, withdrawal of consent or in the opinion of the investigator, the subject is no longer benefiting from treatment.
Dose escalation carried out as follows:
Dose-level 1: 250 mg of EMD 525797 i.v. Dose-level 2: 500 mg dose of EMD 525797 i.v. Dose-level 3: 1000 mg dose of EMD 525797 i.v. Dose-level 4: 1500 mg dose of EMD 525797 i.v.
|Institut Jules Bordet - Medical Oncology Clinic|
|Universitätsklinikum Aachen, AÖR - Medizinische Fakultät der RWTH - Klinik für Urologie|
|Universitätsklinikum "Carl Gustav Carus" Dresden - Klinik und Poliklinik für Urologie|
|Klinikum Rechts der Isar - Urologische Klinik und Poliklinik|
|Study Director:||Wolfgang Uhl, Dr, Dipl. Chem., Physician||Merck KGaA|