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

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ClinicalTrials.gov Identifier: NCT00350051
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Sagopilone (ZK 219477) + prednisone Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety & Tolerability of ZK-Epo plus prednisone [ Time Frame: until progression, unknown duration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 1406FWY
Buenos Aires, Argentina, C1405DCS
Buenos Aires, Argentina, C1416CRJ
Córdoba, Argentina, X5016KEH
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
Click here and search for websynopsis result provided by Bayer  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00350051     History of Changes
Obsolete Identifiers: NCT00430222
Other Study ID Numbers: 91500
307976 ( Other Identifier: Company internal )
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

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
Prednisone
 Androgens
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents