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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Sagopilone (ZK 219477) + prednisone | Phase 2 |
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
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 |