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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003216-30 | EudraCT Number | ||
| 309544 | Other Identifier | Company Internal |
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The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
|
| Arm 3 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
|
| Arm 4 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
|
| Arm 1 | Experimental | Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | 16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate (complete or partial response according to RECIST) | The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7). | Every 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of complete or partial tumor response | Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented | Every 6 weeks |
| Time to tumor progression |
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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 |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
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| Sagopilone (BAY86-5302, ZK 219477) | Drug | 12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. |
|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | 22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. |
|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | 22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6. |
|
Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer |
| Every 6 weeks |
| Vienna |
| State of Vienna |
| 1100 |
| Austria |
| Brasschaat | 2930 | Belgium |
| Plovdiv | 4001 | Bulgaria |
| Sofia | 01784 | Bulgaria |
| Varna | 9000 | Bulgaria |
| Vandœuvre-lès-Nancy | France | 54500 | France |
| Angers | 49033 | France |
| Bordeaux | 33076 | France |
| Clermont-Ferrand | 63011 | France |
| Saint-Herblain | 44805 | France |
| Berlin | State of Berlin | 10117 | Germany |
| Forlì | FC | 47100 | Italy |
| Milan | MI | 20162 | Italy |
| Reggio Emilia | RE | 42100 | Italy |
| Olsztyn | 10-228 | Poland |
| Warsaw | 02-781 | Poland |
| Ljubljana | 1000 | Slovenia |
| Madrid | Madrid | 28040 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Manchester | Greater Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
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