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:

NCT00791778

EudraCT Number:

2008-004429-41

EU CT Number:

Not Available

Study Completed

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
246
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Georgia Health Sciences University

Augusta, United States, 30912

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Centre Léon Bérard

LYON CEDEX, France, 39373

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Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

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Centre Henry Kaplan / CHU TOURS

Tours, France, 37044

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Szpiatal Kliniczny nr 1 Przemienienia Panskiego

Poznan, Poland, 61-878

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Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

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Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie

Bialystok, Poland, 15-027

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Jichi Medical University Hospital

Shimotsuke, Japan, 329-0498

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IRCCS Ist Europeo Oncologia

Milano, Italy, 20141

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Fondazione di Ricerca e Cura Giovanni Paolo II

Campobasso, Italy, 00168

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

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Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

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Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

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Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

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Maine Medical Partners/Women's Health

Scarborough, United States, 04074

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Shands Jacksonville Medical Center

Jacksonville, United States, 32209

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Scripps Cancer Center

La Jolla, United States, 92037

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Centre François Baclesse - CLCC - Caen

CAEN CEDEX 5, France, 14076

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Centre PAUL PAPIN

ANGERS cedex 9, France, 49933

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Szpital Morski im. PCK Gdynskie Centrum Onkologii

Gdynia, Poland, 81-519

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Wielkopolskie Centrum Onkologii

Poznan, Poland, 61-866

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Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

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Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland

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The Jikei University Hospital

Minato-ku, Japan, 105-8471

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The Cancer Institute Hospital of JFCR

Koto-ku, Japan, 135-8550

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Tokai University Hospital

Isehara, Japan, 259-1193

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The Jikei University of Medicine, Kashiwa Hospital

Kashiwa, Japan, 277-8567

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CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

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Juravinski Cancer Centre

Hamilton, Canada, L8V 5C2

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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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CH de Jolimont - Lobbes Site de Jolimont

LA LOUVIERE, Belgium, 7100

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UZ Antwerpen

EDEGEM, Belgium, 2650

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UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

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Samsung Medical Center

Seoul, South Korea, 135-710

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Seoul National University Hospital

Seoul, South Korea, 110-744

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Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

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Kuopion yliopistollinen sairaala

Kuopio, Finland, FIN- 70211

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Keski-Suomen keskussairaala

Jyväskylä, Finland, FI-40620

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Queen Mary Hospital

HongKong, Hong Kong, China

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National University Hospital

Singapore, Singapore, 119228

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Aichi Cancer Center Hospital

Nagoya, Japan, 464-8681

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Università Cattolica del Sacro Cuore

Roma, Italy, 00168

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IRST Istituto Scientifico Romagnolo per studio e cura Tumori

Meldola, Italy, 47014

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Congregazione Figli Immacolata Concezione

Roma, Italy, 00167

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Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

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Hopsital Lucus Agustí

Lugo, Spain, 27003

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London Regional Cancer Program

London, Canada, N6A 4L6

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AZ Sint-Augustinus

WILRIJK, Belgium, 2610

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Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

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Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229 HX

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HagaZiekenhuis, locatie Leyenburg

Den Haag, Netherlands, 2545 CH

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National Cancer Center

Gyeonggi-do, South Korea, 410-769

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Ewha Womans University Hospital

Seoul, South Korea, 158-710

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Asan Medical Center

Seoul, South Korea, 138-736

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Ajou University Hospital

Sowon, South Korea, 443-721

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Keimyung University Dongsan Medical Center

Daegu, South Korea, 700-712

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Gachon University Gil Medical Center

Incheon, South Korea, 405-760

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Queen Elizabeth Hospital

Hong Kong, Hong Kong, China

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KK Women's and Children's Hospital

Singapore, Singapore, 229899

Trial Design