A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
2 other identifiers
interventional
1,021
34 countries
235
Brief Summary
This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve \[AUC\] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m\^2) on Day 1 every 3 weeks or 80 mg/m\^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Dec 2010
235 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
June 10, 2016
CompletedJune 10, 2016
May 1, 2016
4.2 years
November 10, 2010
March 17, 2016
May 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least One Adverse Event (AE)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
Secondary Outcomes (7)
Progression-Free Survival (PFS)
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Duration of Objective Response (DOR)
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
- +2 more secondary outcomes
Study Arms (1)
Bevacizumab + Paclitaxel + Carboplatin
EXPERIMENTALParticipants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m\^2 IV on Day 1 every 3 weeks or 80 mg/m\^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
Interventions
175 mg/m\^2 on Day 1 every 3 weeks or at a dose of 80 mg/m\^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
Eligibility Criteria
You may qualify if:
- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
- Life expectancy greater than or equal to (\>=3) months
You may not qualify if:
- Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
- Planned intraperitoneal cytotoxic chemotherapy
- Radiotherapy within 28 days of Day 1, Cycle 1
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
- History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>=1 arterial thromboembolic event or Grade \>=3 venous thromboembolic event within 6 months prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (242)
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Buenos Aires, C1199ACI, Argentina
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Buenos Aires, C1280AEB, Argentina
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Buenos Aires, C1426ANZ, Argentina
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Rosario, S2002KDS, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Graz, 8020, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Ried-innkreis, 4910, Austria
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Salzburg, 5020, Austria
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Steyr, 4400, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Villach, 9500, Austria
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Fortaleza, Ceará, 60125-120, Brazil
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Salvador, Estado de Bahia, 41950-610, Brazil
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Goiânia, Goiás, 74605-070, Brazil
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Curitiba, Paraná, 80530-010, Brazil
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Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil
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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
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Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
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Piracicaba, São Paulo, 13419-155, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 01308-050, Brazil
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São Paulo, São Paulo, 01317-000, Brazil
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São Paulo, São Paulo, 01509-010, Brazil
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Sofia, 1756, Bulgaria
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Varna, 9010, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Québec, Quebec, G1R 3S1, Canada
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Aalborg, 9000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Cairo, 11555, Egypt
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Tanta, Egypt
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Tallinn, 11312, Estonia
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Tallinn, 13419, Estonia
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Tartu, 50406, Estonia
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Amiens, 80090, France
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Bordeaux, 33076, France
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Brest, 29200, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Grenoble, 38028, France
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Lille, 59020, France
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Lyon, 69373, France
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Marseille, 13273, France
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Mougins, 06250, France
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Paris, 75231, France
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Paris, 75571, France
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Paris, 75651, France
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Paris, 75674, France
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Paris, 75908, France
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Paris, 75970, France
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Reims, 51056, France
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Strasbourg, 67065, France
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Toulouse, 31059, France
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Villejuif, 94805, France
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Athens, 115 28, Greece
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Athens, 11527, Greece
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Athens, 145 64, Greece
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Heraklion, Crete, 71110, Greece
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Larissa, 41 110, Greece
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Pátrai, 265 00, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, 852, Hong Kong
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Hong Kong, Hong Kong
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Debrecen, 4032, Hungary
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Pécs, 7624, Hungary
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Szeged, 6720, Hungary
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Bangalore, 560017, India
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Bangalore, 560054, India
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Hyderabad, 650034, India
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Jaipur, 302013, India
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Kochi, 682304, India
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New Delhi, 110029, India
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Pune, 411004, India
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Dublin, 7, Ireland
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Afula, 18101, Israel
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Beersheba, 8410101, Israel
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Holon, 58100, Israel
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Jerusalem, 91120-01, Israel
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Jerusalem, 9372212, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 7610001, Israel
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Tel Aviv, 64239-06, Israel
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Napoli, Campania, 80131, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Meldola, Emilia-Romagna, 47014, Italy
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Rome, Lazio, 00128, Italy
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Rome, Lazio, 00157, Italy
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Genoa, Liguria, 16128, Italy
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Brescia, Lombardy, 25123, Italy
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Milan, Lombardy, 20141, Italy
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Milan, Lombardy, 20162, Italy
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Monza, Lombardy, 20052, Italy
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Saronno, Lombardy, 21047, Italy
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Novara, Piedmont, 28100, Italy
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Turin, Piedmont, 10126, Italy
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Turin, Piedmont, 10128, Italy
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Palermo, Sicily, 90146, Italy
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Florence, Tuscany, 50139, Italy
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Pisa, Tuscany, 56126, Italy
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Perugia, Umbria, 06123, Italy
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Terni, Umbria, 05100, Italy
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Ash Shuwaykh, 70653, Kuwait
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Daugavpils, 5417, Latvia
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Riga, LV 1079, Latvia
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Riga, LV-1002, Latvia
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Kaunas, 50009, Lithuania
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Klaipėda, 92288, Lithuania
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Vilnius, 08660, Lithuania
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Distrito Federal, 14080, Mexico
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Oaxaca City, 68000, Mexico
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Toluca, 50180, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Apeldoorn, 7334 DZ, Netherlands
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Blaricum, 1261 AN, Netherlands
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Breda, 4819 EV, Netherlands
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Capelle aan den IJssel, NL 2900 AR, Netherlands
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Deventer, 7416 SE, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Leidschendam, 2262 BA, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Sittard-Geleen, 6162 BG, Netherlands
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The Hague, 2512 VA, Netherlands
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The Hague, 2545 CH, Netherlands
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Utrecht, 3582 KE, Netherlands
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Bitola, 7000, North Macedonia
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Skopje, 1000, North Macedonia
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Bydgoszcz, 85-796, Poland
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Warsaw, 03-242, Poland
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Porto, 4200-072, Portugal
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Bucharest, 022328, Romania
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Cluj-Napoca, 400015, Romania
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Iași, 700106, Romania
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Barnaul, 656049, Russia
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Moscow, 115478, Russia
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Obninsk, Kaluzhskaya Region, 249034, Russia
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Saint Petersburg, 197022, Russia
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Stavropol, 355045, Russia
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Ufa, 450054, Russia
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Dammam, 31444, Saudi Arabia
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Belgrade, 11000, Serbia
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Niš, 18000, Serbia
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Bratislava, 833 10, Slovakia
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Košice, 04001, Slovakia
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Durban, 4058, South Africa
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Johannesburg, 2193, South Africa
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Sandton, 2196, South Africa
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Albacete, Albacete, 02006, Spain
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Alicante, Alicante, 3010, Spain
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Elda, Alicante, 03600, Spain
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Badajoz, Badajoz, 06080, Spain
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Llerena (Badajoz), Badajoz, 06900, Spain
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Palma de Mallorca, Balearic Islands, 07014, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08017, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08906, Spain
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Manresa, Barcelona, 08243, Spain
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Burgos, Burgos, 09006, Spain
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Cáceres, Caceres, 10003, Spain
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Cadiz, Cadiz, 11009, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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Castellon, Castellon, 12002, Spain
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Ciudad Real, Ciudad Real, 13005, Spain
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Córdoba, Cordoba, 14004, Spain
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Girona, Girona, 17007, Spain
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Granada, Granada, 18014, Spain
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Guadalajara, Guadalajara, 19002, Spain
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Donostia / San Sebastian, Guipuzcoa, 20080, Spain
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San Sebastián de los Reyes, Guipuzcoa, 28702, Spain
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Jaén, Jaen, 23007, Spain
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A Coruña, La Coruña, 15006, Spain
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Santiago de Compostela, La Coruña, 15706, Spain
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Las Palmas de Gran Canaria, Las Palmas, 35020, Spain
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Lugo, Lugo, 27003, Spain
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Leganés, Madrid, 28911, Spain
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Madrid, Madrid, 28002, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28033, Spain
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Madrid, Madrid, 28040, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28050, Spain
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Madrid, Madrid, 28222, Spain
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Málaga, Malaga, 29010, Spain
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Málaga, Malaga, 29011, Spain
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Navarra, Navarre, 31008, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Salamanca, Salamanca, 37007, Spain
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Segovia, Segovia, 40002, Spain
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Seville, Sevilla, 41009, Spain
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Seville, Sevilla, 41014, Spain
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Reus, Tarragona, 43204, Spain
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San Cristóbal de La Laguna, Tenerife, 38320, Spain
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Santa Cruz de Tenerife, Tenerife, 38010, Spain
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Toledo, Toledo, 45004, Spain
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San Juan, Valencia, 03550, Spain
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Valencia, Valencia, 46009, Spain
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Valencia, Valencia, 46015, Spain
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Valencia, Valencia, 46017, Spain
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Valencia, Valencia, 46026, Spain
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Valladolid, Valladolid, 47010, Spain
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Barakaldo, Vizcaya, 48903, Spain
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Bilbao, Vizcaya, 48013, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Eskilstuna, 63188, Sweden
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Falun, 79182, Sweden
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Karlstad, 65185, Sweden
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Örebro, 701 85, Sweden
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Umeå, Sweden
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Uppsala, 75185, Sweden
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Aarau, 5001, Switzerland
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Baden, 5405, Switzerland
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Bellinzona, 6500, Switzerland
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Bern, 3010, Switzerland
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Geneva, 1211, Switzerland
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Zurich, 8091, Switzerland
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Taipei, 110, Taiwan
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Taipei, 112, Taiwan
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Taoyuan Hsien, 333, Taiwan
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06500, Turkey (Türkiye)
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Diyarbakır, 10000, Turkey (Türkiye)
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Istanbul, 34390, Turkey (Türkiye)
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Montevideo, 11600, Uruguay
Related Publications (1)
Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, Gonzalez-Martin A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836.
PMID: 27749456DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2010
First Posted
November 11, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 10, 2016
Results First Posted
June 10, 2016
Record last verified: 2016-05