Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
NCT ID: NCT00494299
Last Updated: 2013-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
458 participants
INTERVENTIONAL
2006-04-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Placebo
Placebo: matching placebo
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Placebo
Placebo: matching placebo
Eligibility Criteria
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Inclusion Criteria
* Aged of 18 and over
* Advanced hepatocellular carcinoma
Exclusion Criteria
* Failure in vital organ
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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Nagoya, Aichi-ken, Japan
Chiba, Chiba, Japan
Kashiwa, Chiba, Japan
Matsuyama, Ehime, Japan
Tōon, Ehime, Japan
Fukui-shi, Fukui, Japan
Fukuoka, Fukuoka, Japan
Iizuka, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Gifu, Gifu, Japan
Isesaki, Gunma, Japan
Maebashi, Gunma, Japan
Hiroshima, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Kure, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Akashi, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kasama, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Isehara, Kanagawa, Japan
Sagamihara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Kumamoto, Kumamoto, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Sendai, Miyagi, Japan
Miyazaki, Miyazaki, Japan
Matsumoto, Nagano, Japan
Ōmura, Nagasaki, Japan
Okayama, Okayama-ken, Japan
Kawachi-Nagano, Osaka, Japan
Moriguchi, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Suita, Osaka, Japan
Izunokuni, Shizuoka, Japan
Sunto, Shizuoka, Japan
Shimotsuke, Tochigi, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Musashino, Tokyo, Japan
Nerima-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Yonago, Tottori, Japan
Toyama, Toyama, Japan
Yamagata, Yamagata, Japan
Shimonoseki, Yamaguchi, Japan
Ube, Yamaguchi, Japan
Chūō, Yamanashi, Japan
Seoul, Seoul Teugbyeolsi, South Korea
Daegu, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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References
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Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.
Other Identifiers
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11721
Identifier Type: -
Identifier Source: org_study_id