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| Name | Class |
|---|---|
| Crown Bioscience | INDUSTRY |
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The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Karenitecin | Experimental |
| |
| Topotecan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Karenitecin | Drug | Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | baseline to measured progressive disease |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | baseline to date of death from any cause | |
| Incidence of Anemia | Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Budapest | 1032 | Hungary | ||||
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| Label | URL |
|---|---|
| MedlinePlus related topic: Ovarian Cancer | View source |
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| Topotecan | Drug | Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days) |
|
|
| Incidence of Neutropenia | Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration |
| Incidence of Thrombocytopenia | Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration |
| Budapest |
| 1082 |
| Hungary |
| Budapest | 1088 | Hungary |
| Győr | 9024 | Hungary |
| Kaunas | 50009 | Lithuania |
| Klaipėda | 92288 | Lithuania |
| Elblag | 82-300 | Poland |
| Krakow | 31-501 | Poland |
| Lublin | 20-090 | Poland |
| Olsztyn | 10-228 | Poland |
| Oploe | 45-060 | Poland |
| Poznan | 60-535 | Poland |
| Poznan | 61-866 | Poland |
| Szczecin | 70-111 | Poland |
| Tarnów | 33-100 | Poland |
| Bucharest | 022328 | Romania |
| Bucharest | 500098 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Craiova | 200535 | Romania |
| Iași | 700106 | Romania |
| Oradea | 410159 | Romania |
| Sibiu | 550245 | Romania |
| Suceava County | 720237 | Romania |
| Târgu Mureş | 540072 | Romania |
| Ulan-Ude | Rep. of Buryatiya | 670047 | Russia |
| Engel's | Saratov Oblast | 413115 | Russia |
| Isvesk | Udmurtiya Republic | 426009 | Russia |
| Arkhangelsk | 163045 | Russia |
| Birobidzhan | 679016 | Russia |
| Khabarovsk | 680042 | Russia |
| Krasnodar | 350040 | Russia |
| Kursk | 305035 | Russia |
| Magnitogorsk | 455001 | Russia |
| Nizhny Novgorod | 603109 | Russia |
| Novosibirsk | 630108 | Russia |
| Orenburg | 460021 | Russia |
| Petrozavodsk | 185007 | Russia |
| Pyatigorsk | 357502 | Russia |
| Ryazan | 390011 | Russia |
| Saint Petersburg | 191104 | Russia |
| Saint Petersburg | 198255 | Russia |
| Sochi | 354057 | Russia |
| Stavropol | 355047 | Russia |
| Syktyvkar | 167904 | Russia |
| Tambov | 392013 | Russia |
| Ufa | 450054 | Russia |
| Vladimir | 600020 | Russia |
| Vladivostok | 690105 | Russia |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C406143 | cositecan |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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