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Sponsored by: |
Cytavis Biopharma GmbH |
Information provided by: | Cytavis Biopharma GmbH |
ClinicalTrials.gov Identifier: | NCT00658437 |
The trial is designed as a phase II evaluation of the effect of CY-503 on progression free survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy. The aim of the study is at least a rate of 25% (PFS >/= 3 months).
Condition | Intervention | Phase |
Melanoma |
Drug: CY-503 |
Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Multicenter Study to Test Progression-Free and Overall Survival of CY-503 in the Treatment of Patients With Unresectable Stage IV Metastatic Melanoma After Antineoplastic Treatment Failure |
Estimated Enrollment: | 29 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter Mohr, MD | +49 4161 703 ext 6212 | peter.mohr@elbekliniken.de |
Germany | |||||
Haut Tumor Zentrum Charité | Recruiting | ||||
Berlin, Germany, D-10117 | |||||
Contact: Uwe Trefzer, Prof, MD +49 30 450 ext 518 016 uwe.trefzer@charite.de | |||||
Principal Investigator: Uwe Trefzer, Prof, MD | |||||
Dermatologisches Zentrum Elbe-Klinikum Buxtehude | Recruiting | ||||
Buxtehude, Germany, D-21603 | |||||
Contact: Ines Maintz +49 4161 703 ext 6212 heike.gleiss@elbekliniken.de | |||||
Principal Investigator: Peter Mohr, MD | |||||
Hautklinik Linden MH Hannover | Recruiting | ||||
Hannover, Germany, D-30449 | |||||
Contact: Ralf Gutzmer, Prof, MD +49 511 9246 ext 0 Gutzmer.ralf@mh.hannover.de | |||||
Principal Investigator: Ralf Gutzmer, Prof, MD | |||||
Universitäts-Hautklinik Kiel | Recruiting | ||||
Kiel, Germany, D-24105 | |||||
Contact: Susanne Schwieck +49 431 597 ext 3994 | |||||
Principal Investigator: Axel Hauschild, Prof, MD |
Cytavis Biopharma GmbH |
Responsible Party: | Industry ( Cytavis Biopharma GmbH ) |
Study ID Numbers: | CY503C1, EudraCT no. 2007-000427-17 |
First Received: | April 9, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00658437 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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