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| ID | Type | Description | Link |
|---|---|---|---|
| 307975 | 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) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (ZK 219477) | Drug | All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment with ZK-Epo after 6 cycles | complete or partial response after 2 to 6 courses of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of ZK-Epo | time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR. |
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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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20697802 | Derived | Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10. |
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| Sagopilone (ZK 219477) | Drug | Patients will receive 22mg/m2 as intravenous infusion. |
|
|
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Tucson | Arizona | 85724 | United States |
| Hot Springs | Arkansas | 71913 | United States |
| Bakersfield | California | 93309 | United States |
| Palm Springs | California | 92262 | United States |
| Aurora | Colorado | 80010 | United States |
| Washington D.C. | District of Columbia | 20007 | United States |
| Daytona Beach | Florida | 32114 | United States |
| Decatur | Illinois | 62526 | United States |
| New Albany | Indiana | 47150 | United States |
| Baltimore | Maryland | 21204 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Livingston | New Jersey | 07039 | United States |
| New York | New York | 10021 | United States |
| Syracuse | New York | 13210 | United States |
| Portland | Oregon | 97239 | United States |
| Pittsburgh | Pennsylvania | 15213-3180 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78207 | United States |
| Tacoma | Washington | 98405 | United States |
| Toronto | Ontario | M4N 3M5 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Québec | Quebec | G1S 4L8 | Canada |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
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