ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00350051
First received: July 7, 2006
Last updated: December 2, 2014
Last verified: December 2014
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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 2 |
| 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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350051
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:
Publications:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00350051 History of Changes |
| Obsolete Identifiers: | NCT00430222 |
| Other Study ID Numbers: | 91500, 307976 |
| Study First Received: | July 7, 2006 |
| Last Updated: | December 2, 2014 |
| 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 Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Prednisone Anti-Inflammatory Agents |
Antineoplastic Agents Antineoplastic Agents, Hormonal Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015