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

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

Loading...
Locations
Status
LocationsStatus
Locations

Georgia Health Sciences University

Augusta, United States, 30912

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 39373

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Centre Henry Kaplan / CHU TOURS

Tours, France, 37044

Status
Completed
 
Locations

Szpiatal Kliniczny nr 1 Przemienienia Panskiego

Poznan, Poland, 61-878

Status
Completed
 
Locations

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

Status
Completed
 
Locations

Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie

Bialystok, Poland, 15-027

Status
Completed
 
Locations

Jichi Medical University Hospital

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

IRCCS Ist Europeo Oncologia

Milano, Italy, 20141

Status
Completed
 
Locations

Fondazione di Ricerca e Cura Giovanni Paolo II

Campobasso, Italy, 00168

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Maine Medical Partners/Women's Health

Scarborough, United States, 04074

Status
Completed
 
Locations

Shands Jacksonville Medical Center

Jacksonville, United States, 32209

Status
Completed
 
Locations

Scripps Cancer Center

La Jolla, United States, 92037

Status
Completed
 
Locations

Centre François Baclesse - CLCC - Caen

CAEN CEDEX 5, France, 14076

Status
Completed
 
Locations

Centre PAUL PAPIN

ANGERS cedex 9, France, 49933

Status
Completed
 
Locations

Szpital Morski im. PCK Gdynskie Centrum Onkologii

Gdynia, Poland, 81-519

Status
Completed
 
Locations

Wielkopolskie Centrum Onkologii

Poznan, Poland, 61-866

Status
Completed
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland

Status
Completed
 
Locations

The Jikei University Hospital

Minato-ku, Japan, 105-8471

Status
Completed
 
Locations

The Cancer Institute Hospital of JFCR

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Tokai University Hospital

Isehara, Japan, 259-1193

Status
Completed
 
Locations

The Jikei University of Medicine, Kashiwa Hospital

Kashiwa, Japan, 277-8567

Status
Completed
 
Locations

CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

Status
Completed
 
Locations

Juravinski Cancer Centre

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

CH de Jolimont - Lobbes Site de Jolimont

LA LOUVIERE, Belgium, 7100

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Kuopion yliopistollinen sairaala

Kuopio, Finland, FIN- 70211

Status
Completed
 
Locations

Keski-Suomen keskussairaala

Jyväskylä, Finland, FI-40620

Status
Completed
 
Locations

Queen Mary Hospital

HongKong, Hong Kong, China

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119228

Status
Completed
 
Locations

Aichi Cancer Center Hospital

Nagoya, Japan, 464-8681

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

IRST Istituto Scientifico Romagnolo per studio e cura Tumori

Meldola, Italy, 47014

Status
Completed
 
Locations

Congregazione Figli Immacolata Concezione

Roma, Italy, 00167

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Hopsital Lucus Agustí

Lugo, Spain, 27003

Status
Completed
 
Locations

London Regional Cancer Program

London, Canada, N6A 4L6

Status
Completed
 
Locations

AZ Sint-Augustinus

WILRIJK, Belgium, 2610

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229 HX

Status
Completed
 
Locations

HagaZiekenhuis, locatie Leyenburg

Den Haag, Netherlands, 2545 CH

Status
Completed
 
Locations

National Cancer Center

Gyeonggi-do, South Korea, 410-769

Status
Completed
 
Locations

Ewha Womans University Hospital

Seoul, South Korea, 158-710

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Ajou University Hospital

Sowon, South Korea, 443-721

Status
Completed
 
Locations

Keimyung University Dongsan Medical Center

Daegu, South Korea, 700-712

Status
Completed
 
Locations

Gachon University Gil Medical Center

Incheon, South Korea, 405-760

Status
Completed
 
Locations

Queen Elizabeth Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Status
Completed
 

Trial Design