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This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edotecarin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Time to tumor response (TAR) | ||
| Duration of response (DR) | ||
| Time to tumor progression (TTP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Manhasset | New York | 11030 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Time to treatment failure (TTF) |
| Overall survival (OS) |
| Clinical benefit |
| ie, a composite profile of pain intensity |
| analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18] |
| performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2] |
| Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC] |
| [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities. |
| Plasma pharmacokinetic parameters |
| New York |
| New York |
| 10021 |
| United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44121 | United States |
| Pfizer Investigational Site | Orange | Ohio | 44122 | United States |
| Pfizer Investigational Site | Westlake | Ohio | 44145 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | East Bentleigh | Victoria | 3165 | Australia |
| Pfizer Investigational Site | Parkville | Victoria | 3050 | Australia |
| Pfizer Investigational Site | Brussels | 1090 | Belgium |
| Pfizer Investigational Site | Charleroi | B-6000 | Belgium |
| Pfizer Investigational Site | Haine-Saint-Paul | 7100 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Wilrijk | 2610 | Belgium |
| Pfizer Investigational Site | Dijon | 21034 | France |
| Pfizer Investigational Site | Montpellier | 34059 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Toulouse | 31052 | France |
| Pfizer Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| 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 |
|---|---|
| C121395 | edotecarin |
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