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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016151-21 | EudraCT Number |
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The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel and pazopanib | Experimental |
| |
| paclitaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug | 80 mg/m2 IV days 1, 8, 15 every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | 6 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with objective response | at 2 months and 4 months after randomization | |
| worst grade toxicity per patient | at end of each 28 day cycle of therapy | |
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Inclusion Criteria:
Exclusion Criteria:
· • Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
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| Name | Affiliation | Role |
|---|---|---|
| Sandro Pignata, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Francesco Perrone, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Ciro Gallo, M.D., Ph.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osp. Regionale Mulli | Acquaviva delle Fonti | Italy | ||||
| Ospedale San donato |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25882986 | Background | Pignata S, Lorusso D, Scambia G, Sambataro D, Tamberi S, Cinieri S, Mosconi AM, Orditura M, Brandes AA, Arcangeli V, Panici PB, Pisano C, Cecere SC, Di Napoli M, Raspagliesi F, Maltese G, Salutari V, Ricci C, Daniele G, Piccirillo MC, Di Maio M, Gallo C, Perrone F; MITO 11 investigators. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial. Lancet Oncol. 2015 May;16(5):561-8. doi: 10.1016/S1470-2045(15)70115-4. Epub 2015 Apr 14. | |
| 37185961 |
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| pazopanib | Drug | orally, 800 mg orally daily |
|
| overall survival |
| one year from randomization |
| Arezzo |
| Italy |
| A.O. G. Rummo | Benevento | Italy |
| Ospedale Bellaria | Bologna | Italy |
| Ospedale Senatore Antonio Perrino | Brindisi | Italy |
| A.O. Garibaldi Nesimadi Catania | Catania | Italy |
| Ospedale Civile di Faenza | Faenza | Italy |
| A.O.U. Arcispedale Sant'Anna di Ferrara | Ferrara | Italy |
| Ospedale Fabrizio Spaziani della ASL di Frosinone | Frosinone | Italy |
| Ospedale Umbero I | Lugo | Italy |
| Istituto Nazionale Tumori | Milan | Italy |
| A.O. Univeristaria Policlinico | Modena | Italy |
| Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico | Naples | 80131 | Italy |
| Seconda Universita di Napoli | Naples | Italy |
| Ospedale Silvestrini | Perugia | Italy |
| Ospedale S. Maria delle Croci AUSL di Ravenna | Ravenna | Italy |
| A.O. Bainchi Melacrino Morelli Osp. Riuniti | Reggio Calabria | Italy |
| Ospedale degli Infermi, P.O. Ospedale Civile | Rimini | Italy |
| Policlinico Umberto I | Roma | Italy |
| Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore | Roma | Italy |
| Derived |
| Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
|---|---|
| D017239 | Paclitaxel |
| C516667 | pazopanib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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