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This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO906 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epothilone b | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate | tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). | Every 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | from start of treatment to documented disease progression, death from study indication, or the date of last follow-up | |
| Overall survival | measured from the start of treatment to the date of death or the last date the patient was known to be alive. |
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Inclusion Criteria:
The following patients may be eligible for the study:
Exclusion Criteria:
The following patients are not eligible for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | New Brunswick | New Jersey | 08901 | United States | ||
| Novartis Investigative Site |
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| Duration of response | duration of response in patients with complete response (CR) or partial response (PR) | Every 3 months |
| recording all adverse events (AEs) and serious adverse events (SAEs) | Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations | Every 3 months |
| pharmacogenetic analyses with blood and tumor samples from these patients | Every 3 months |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Novartis Investigative Site | Enschede | Netherlands | 7513 ER | Netherlands |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Zwolle | 8025 AB | Netherlands |
| Novartis Investigative Site | Bratislava | 812 50 | Slovakia |
| Novartis Investigative Site | Košice | 04190 | Slovakia |
| Novartis Investigative Site | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D005184 | Fallopian Tube Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
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