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

Sponsor:	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: Sagopilone (ZK 219477) + prednisone	Phase II

Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone

U.S. FDA Resources

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:	53
Study Start Date:	August 2006
Study Completion Date:	December 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Sagopilone (ZK 219477) + prednisone Chemotherapy for hormone refractory prostate cancer; 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, Ciudad Auton. de Buenos Aires, Argentina, C1280AEB

Buenos Aires, Argentina, C1416CRJ

Buenos Aires, Argentina, 1406FWY

Buenos Aires, Argentina, C1405DCS

Córdoba, Argentina, X5016KEH

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00350051 History of Changes
Obsolete Identifiers:	NCT00430222
Other Study ID Numbers:	91500, 307976
Study First Received:	July 7, 2006
Last Updated:	November 8, 2011
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

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Prednisone

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012