| ID | Type | Description | Link |
|---|---|---|---|
| 307976 | Other Identifier | Company internal |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (ZK 219477) + prednisone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles | at least 28 days post day 21 of last cycle of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Tolerability of ZK-Epo plus prednisone | until progression, unknown duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fountain Valley | California | 92708 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22850553 | Result | Beer TM, Smith DC, Hussain A, Alonso M, Wang J, Giurescu M, Roth K, Wang Y. Phase II study of first-line sagopilone plus prednisone in patients with castration-resistant prostate cancer: a phase II study of the Department of Defense Prostate Cancer Clinical Trials Consortium. Br J Cancer. 2012 Aug 21;107(5):808-13. doi: 10.1038/bjc.2012.339. Epub 2012 Jul 31. |
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| Sarasota |
| Florida |
| 34237 |
| United States |
| Baltimore | Maryland | 21201 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Billings | Montana | 59101 | United States |
| Omaha | Nebraska | 68198-7680 | United States |
| The Bronx | New York | 10469 | United States |
| Canton | Ohio | 44718 | United States |
| Portland | Oregon | 97201 | United States |
| Altoona | Pennsylvania | 16601 | United States |
| Fort Worth | Texas | 76104 | United States |
| Seattle | Washington | 98108-1597 | United States |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1280AEB | Argentina |
| Buenos Aires | 1406 | Argentina |
| Buenos Aires | C1405DCS | Argentina |
| Buenos Aires | C1416CRJ | Argentina |
| Córdoba | X5016KEH | Argentina |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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