ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-Independent Prostate Cancer - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00350051

Purpose

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.

Condition	Intervention	Phase
Prostate Cancer	Drug: SH-Y03757A (ZK-Epothilone; ZK-219477) with prednisone	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Ixabepilone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-Line Chemotherapy in Patients With Metastatic Androgen-Independent Prostate Cancer

Further study details as provided by Bayer:

Primary Outcome Measures:

PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles [ Time Frame: at least 28 days post day 21 of last cycle of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety & Tolerability of ZK-Epo plus prednisone [ Time Frame: until progression, unknown duration ] [ Designated as safety issue: Yes ]

Enrollment:	46
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: SH-Y03757A (ZK-Epothilone; ZK-219477) with prednisone Chemotherapy for hormone refractory prostate cacner; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.

Detailed Description:

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have evidence of confirmed metastatic prostate cancer
Serum testosterone must be less than 50 ng/mL
Disease must be progressing despite anti-androgen therapy
PSA level must be elevated
Additional criteria determined at screening visit

Exclusion Criteria:

Any previous cytotoxic chemotherapy for prostate cancer
Use of any investigational drug in the last 4 weeks
Symptomatic brain tumors requiring radiation to the brain
Active infection
Additional criteria determined at screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350051

Locations

United States, California

Fountain Valley, California, United States, 92708
United States, Florida

Sarasota, Florida, United States, 34237
United States, Maryland

Baltimore, Maryland, United States, 21201
United States, Michigan

Ann Arbor, Michigan, United States, 48109-0330
United States, Montana

Billings, Montana, United States, 59101
United States, Nebraska

Omaha, Nebraska, United States, 68198
United States, New York

Bronx, New York, United States, 10469
United States, Ohio

Canton, Ohio, United States, 44718
United States, Oregon

Portland, Oregon, United States, 97201-2999
United States, Pennsylvania

Altoona, Pennsylvania, United States, 16601
United States, Texas

Fort Worth, Texas, United States, 76104
United States, Washington

Seattle, Washington, United States, 98108-1597
Argentina

Buenos Aires, Argentina, C1405DCS

Buenos Aires, Argentina, C1416CRJ

Córdoba, Argentina, 5016
Argentina, Capital Federal

Buenos Aires, Capital Federal, Argentina, C1406FWY

Buenos Aires, Capital Federal, Argentina, C1280AEB

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

This study is the same study protocol as NCT00430222, with different locations. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91500, 307976
Study First Received:	July 7, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00350051
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Bayer:

Prostate cancer
Metastatic androgen-independent prostate cancer

Study placed in the following topic categories:

Prednisone
Prostatic Diseases
Genital Neoplasms, Male
Epothilones

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents

Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on January 14, 2009