Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer
NCT ID: NCT00791778
Last Updated: 2015-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
246 participants
INTERVENTIONAL
2008-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
Sorafenib (Nexavar, BAY43-9006)
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
Placebo
Participants received 2 matching placebo tablets per oral twice daily
Placebo
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Patients in Sorafenib arm will receive 2 Sorafenib tablets (200 mg each) twice a day and in continuous administration.
Placebo
Patients in Placebo arm will receive 2 matching placebo tablets twice a day and in continuous administration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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La Jolla, California, United States
Jacksonville, Florida, United States
Augusta, Georgia, United States
Scarborough, Maine, United States
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
La Louvière, , Belgium
Leuven, , Belgium
Wilrijk, , Belgium
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Jyväskylä, , Finland
Kuopio, , Finland
Angers, , France
Caen, , France
Lyon, , France
Tours, , France
Villejuif, , France
Berlin, State of Berlin, Germany
Hong Kong, , Hong Kong
Meldola, Forlì, Italy
Campobasso, , Italy
Milan, , Italy
Roma, , Italy
Roma, , Italy
Nagoya, Aichi-ken, Japan
Kashiwa, Chiba, Japan
Isehara, Kanagawa, Japan
Shimotsuke, Tochigi, Japan
Koto-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Maastricht, , Netherlands
The Hague, , Netherlands
Bialystok, , Poland
Gdynia, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Poznan, , Poland
Warsaw, , Poland
Singapore, , Singapore
Singapore, , Singapore
Seoul, Seoul Teugbyeolsi, South Korea
Daegu, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Sŏwŏn, , South Korea
Sabadell, Barcelona, Spain
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
Countries
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References
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Herzog TJ, Scambia G, Kim BG, Lhomme C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2008-004429-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12007
Identifier Type: -
Identifier Source: org_study_id
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