check_circleStudy Completed
Ovarian Neoplasms
Bayer Identifier:
12007
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Comparison of Nexavar/Placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancer
Trial purpose
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
246Trial Dates
November 2008 - December 2012Phase
Phase 2Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Georgia Health Sciences University | Augusta, 30912, United States |
Completed | Centre Léon Bérard | LYON CEDEX, 39373, France |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Completed | Centre Henry Kaplan / CHU TOURS | Tours, 37044, France |
Completed | Szpiatal Kliniczny nr 1 Przemienienia Panskiego | Poznan, 61-878, Poland |
Completed | Centrum Onkologii Instytut im. M. Sklodowskiej-Curie | Krakow, 31-115, Poland |
Completed | Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie | Bialystok, 15-027, Poland |
Completed | Jichi Medical University Hospital | Shimotsuke, 329-0498, Japan |
Completed | IRCCS Ist Europeo Oncologia | Milano, 20141, Italy |
Completed | Fondazione di Ricerca e Cura Giovanni Paolo II | Campobasso, 00168, Italy |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Hospital Universitario 12 de Octubre | Madrid, 28041, Spain |
Completed | Corporació Sanitària Parc Taulí | Sabadell, 08208, Spain |
Completed | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Completed | Charité Campus Virchow-Klinikum (CVK) | Berlin, 13353, Germany |
Completed | Maine Medical Partners/Women's Health | Scarborough, 04074, United States |
Completed | Shands Jacksonville Medical Center | Jacksonville, 32209, United States |
Completed | Scripps Cancer Center | La Jolla, 92037, United States |
Completed | Centre François Baclesse - CLCC - Caen | CAEN CEDEX 5, 14076, France |
Completed | Centre PAUL PAPIN | ANGERS cedex 9, 49933, France |
Completed | Szpital Morski im. PCK Gdynskie Centrum Onkologii | Gdynia, 81-519, Poland |
Completed | Wielkopolskie Centrum Onkologii | Poznan, 61-866, Poland |
Completed | Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie | Warszawa, 02-781, Poland |
Completed | Centrum Onkologii Ziemi Lubelskiej | Lublin, Poland |
Completed | The Jikei University Hospital | Minato-ku, 105-8471, Japan |
Completed | The Cancer Institute Hospital of JFCR | Koto-ku, 135-8550, Japan |
Completed | Tokai University Hospital | Isehara, 259-1193, Japan |
Completed | The Jikei University of Medicine, Kashiwa Hospital | Kashiwa, 277-8567, Japan |
Completed | CHUM - Hopital Notre-Dame | Montreal, H2L 4M1, Canada |
Completed | Juravinski Cancer Centre | Hamilton, L8V 5C2, Canada |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | CH de Jolimont - Lobbes Site de Jolimont | LA LOUVIERE, 7100, Belgium |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Samsung Medical Center | Seoul, 135-710, Korea, Republic Of |
Completed | Seoul National University Hospital | Seoul, 110-744, Korea, Republic Of |
Completed | Severance Hospital, Yonsei University College of Medicine | Seoul, 120-752, Korea, Republic Of |
Completed | Kuopion yliopistollinen sairaala | Kuopio, FIN- 70211, Finland |
Completed | Keski-Suomen keskussairaala | Jyväskylä, FI-40620, Finland |
Completed | Queen Mary Hospital | HongKong, Hong Kong |
Completed | National University Hospital | Singapore, 119228, Singapore |
Completed | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Completed | Università Cattolica del Sacro Cuore | Roma, 00168, Italy |
Completed | IRST Istituto Scientifico Romagnolo per studio e cura Tumori | Meldola, 47014, Italy |
Completed | Congregazione Figli Immacolata Concezione | Roma, 00167, Italy |
Completed | Hospital Universitario Virgen del Rocío | Sevilla, 41013, Spain |
Completed | Hopsital Lucus Agustí | Lugo, 27003, Spain |
Completed | London Regional Cancer Program | London, N6A 4L6, Canada |
Completed | AZ Sint-Augustinus | WILRIJK, 2610, Belgium |
Completed | Institut Jules Bordet/Jules Bordet Instituut | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Academisch Ziekenhuis Maastricht | Maastricht, 6229 HX, Netherlands |
Completed | HagaZiekenhuis, locatie Leyenburg | Den Haag, 2545 CH, Netherlands |
Completed | National Cancer Center | Gyeonggi-do, 410-769, Korea, Republic Of |
Completed | Ewha Womans University Hospital | Seoul, 158-710, Korea, Republic Of |
Completed | Asan Medical Center | Seoul, 138-736, Korea, Republic Of |
Completed | Ajou University Hospital | Sowon, 443-721, Korea, Republic Of |
Completed | Keimyung University Dongsan Medical Center | Daegu, 700-712, Korea, Republic Of |
Completed | Gachon University Gil Medical Center | Incheon, 405-760, Korea, Republic Of |
Completed | Queen Elizabeth Hospital | Hong Kong, Hong Kong |
Completed | KK Women's and Children's Hospital | Singapore, 229899, Singapore |
Primary Outcome
- Progression-free survival (PFS), based on radiological or pathologic assessmentdate_rangeTime Frame:From randomization of the first patient until 32.5 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to first pathologic CA-125 (cancer-associated tumor marker) serum leveldate_rangeTime Frame:From randomization of the first patient until 32.5 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
- Overall survival (OS)date_rangeTime Frame:From randomization of the first patient until 32.5 months laterenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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