Trial Condition(s):
Ovarian Neoplasms
Comparison of Nexavar/Placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancer
Bayer Identifier:
12007
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment. - Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - All scans used to document complete response must be done within 30 days prior to randomization. - Patients must be able to swallow and retain oral medication.
Exclusion Criteria
- Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI). - Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy. - Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell). - Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Georgia Health Sciences University Augusta, United States, 30912 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Léon Bérard LYON CEDEX, France, 39373 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Gustave Roussy - Villejuif VILLEJUIF, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Henry Kaplan / CHU TOURS Tours, France, 37044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpiatal Kliniczny nr 1 Przemienienia Panskiego Poznan, Poland, 61-878 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Krakow, Poland, 31-115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie Bialystok, Poland, 15-027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jichi Medical University Hospital Shimotsuke, Japan, 329-0498 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Europeo Oncologia Milano, Italy, 20141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fondazione di Ricerca e Cura Giovanni Paolo II Campobasso, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maine Medical Partners/Women's Health Scarborough, United States, 04074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shands Jacksonville Medical Center Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scripps Cancer Center La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre François Baclesse - CLCC - Caen CAEN CEDEX 5, France, 14076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre PAUL PAPIN ANGERS cedex 9, France, 49933 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Morski im. PCK Gdynskie Centrum Onkologii Gdynia, Poland, 81-519 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wielkopolskie Centrum Onkologii Poznan, Poland, 61-866 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Ziemi Lubelskiej Lublin, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Jikei University Hospital Minato-ku, Japan, 105-8471 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokai University Hospital Isehara, Japan, 259-1193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Jikei University of Medicine, Kashiwa Hospital Kashiwa, Japan, 277-8567 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUM - Hopital Notre-Dame Montreal, Canada, H2L 4M1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juravinski Cancer Centre Hamilton, Canada, L8V 5C2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CH de Jolimont - Lobbes Site de Jolimont LA LOUVIERE, Belgium, 7100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kuopion yliopistollinen sairaala Kuopio, Finland, FIN- 70211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keski-Suomen keskussairaala Jyväskylä, Finland, FI-40620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital HongKong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aichi Cancer Center Hospital Nagoya, Japan, 464-8681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRST Istituto Scientifico Romagnolo per studio e cura Tumori Meldola, Italy, 47014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Congregazione Figli Immacolata Concezione Roma, Italy, 00167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopsital Lucus Agustí Lugo, Spain, 27003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Regional Cancer Program London, Canada, N6A 4L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ Sint-Augustinus WILRIJK, Belgium, 2610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Ziekenhuis Maastricht Maastricht, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HagaZiekenhuis, locatie Leyenburg Den Haag, Netherlands, 2545 CH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Gyeonggi-do, South Korea, 410-769 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ewha Womans University Hospital Seoul, South Korea, 158-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ajou University Hospital Sowon, South Korea, 443-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keimyung University Dongsan Medical Center Daegu, South Korea, 700-712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gachon University Gil Medical Center Incheon, South Korea, 405-760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations KK Women's and Children's Hospital Singapore, Singapore, 229899 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression-free survival (PFS), based on radiological or pathologic assessmentTimeframe: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Secondary Outcome
- Time to first pathologic CA-125 (cancer-associated tumor marker) serum levelTimeframe: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
- Overall survival (OS)Timeframe: From randomization of the first patient until 32.5 months later
Additional Information
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