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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.: 2006-006565-16 | |||
| PAREXEL 84728 |
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| Name | Class |
|---|---|
| Maxygen ApS | INDUSTRY |
| Maxygen, Inc. | INDUSTRY |
| Parexel | INDUSTRY |
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This is an investigation of the safety and efficacy of Maxy-G34 in breast cancer patients treated with TAC chemotherapy. Maxy-G34 will be given as a single injection during each cycle of chemotherapy, for a planned total of six chemotherapy cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxy-G34 | Biological | Maxy-G34 will be administered by subcutaneous injection during each of 6 TAC chemotherapy cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycle 1. | over 1 cycle of TAC chemotherapy (approximately 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the duration of grade 4 neutropenia after administration of Maxy-G34 in chemotherapy cycles 2-6. | over cycles 2-6 of TAC chemotherapy (approximately from weeks 4-18) | |
| To determine the incidence of grade 4 neutropenia after administration of each of the 6 doses of Maxy-G34. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doris Apt | Contact | 650-298-5367 | Doris.Apt@maxygen.com |
| Name | Affiliation | Role |
|---|---|---|
| Santosh Vetticaden, MD | Maxygen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Bydgoszcz | Poland | ||||
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| over all 6 cycles of TAC chemotherapy (approximately 18 weeks) |
| Recruiting |
| Gdansk |
| Poland |
| Recruiting | Lublin | Poland |
| Active, not recruiting | Alba Iulia | Romania |
| Active, not recruiting | Bucharest | Romania |
| Recruiting | Jud. Bacau | Romania |
| Recruiting | Suceava | Romania |
| Recruiting | Timișoara | Romania |
| Active, not recruiting | Leningrad Region | Russia |
| Active, not recruiting | Moscow | Russia |
| Recruiting | Moscow Area | Russia |
| Active, not recruiting | Ryazan | Russia |
| Active, not recruiting | Saint Petersburg | Russia |
| Recruiting | Dnipropetrovsk | Ukraine |
| Recruiting | Uzhhorod | Ukraine |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| C545207 | Maxy G34 |
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