Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
1 other identifier
interventional
458
2 countries
75
Brief Summary
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2006
Longer than P75 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
January 20, 2011
CompletedDecember 20, 2013
November 1, 2013
3.3 years
June 28, 2007
December 21, 2010
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression (TTP)
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Secondary Outcomes (1)
Overall Survival (OS)
From randomization of the first subject until 39 months later.
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALSorafenib (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.
Placebo
PLACEBO COMPARATORSorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
Interventions
Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib
Eligibility Criteria
You may qualify if:
- Male or female
- Aged of 18 and over
- Advanced hepatocellular carcinoma
You may not qualify if:
- History of prior systemic chemotherapy
- Failure in vital organ
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (75)
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Nagoya, Aichi-ken, 460-0001, Japan
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Chiba, Chiba, 260-8677, Japan
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Kashiwa, Chiba, 277-8577, Japan
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Matsuyama, Ehime, 791-0280, Japan
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Tōon, Ehime, 791-0295, Japan
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Fukui-shi, Fukui, 918-8503, Japan
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Fukuoka, Fukuoka, 814-0180, Japan
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Iizuka, Fukuoka, 820-8505, Japan
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Kitakyushu, Fukuoka, 802-8533, Japan
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Kitakyushu, Fukuoka, 807-8555, Japan
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Kurume, Fukuoka, 830-0011, Japan
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Gifu, Gifu, 500-8513, Japan
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Isesaki, Gunma, 372-0817, Japan
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Maebashi, Gunma, 371-8511, Japan
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Hiroshima, Hiroshima, 730-8619, Japan
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Hiroshima, Hiroshima, 734-8530, Japan
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Hiroshima, Hiroshima, 734-8551, Japan
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Kure, Hiroshima, 737-0193, Japan
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Sapporo, Hokkaido, 003-0804, Japan
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Sapporo, Hokkaido, 060-0033, Japan
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Akashi, Hyōgo, 673-8558, Japan
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Kobe, Hyōgo, 650-0017, Japan
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Kasama, Ibaraki, 309-1793, Japan
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Kanazawa, Ishikawa-ken, 920-8641, Japan
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Kagoshima, Kagoshima-ken, 890-0061, Japan
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Kagoshima, Kagoshima-ken, 890-8520, Japan
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Kagoshima, Kagoshima-ken, 892-8512, Japan
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Isehara, Kanagawa, 259-1193, Japan
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Sagamihara, Kanagawa, 228-8520, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Yokohama, Kanagawa, 245-8575, Japan
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Kumamoto, Kumamoto, 860-0008, Japan
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Kumamoto, Kumamoto, 860-8556, Japan
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Kumamoto, Kumamoto, 861-4193, Japan
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Kyoto, Kyoto, 606-8507, Japan
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Sendai, Miyagi, 980-8574, Japan
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Sendai, Miyagi, 983-8520, Japan
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Miyazaki, Miyazaki, 880-0003, Japan
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Matsumoto, Nagano, 390-8621, Japan
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Ōmura, Nagasaki, 856-8562, Japan
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Okayama, Okayama-ken, 700-8511, Japan
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Kawachi-Nagano, Osaka, 586-8521, Japan
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Moriguchi, Osaka, 570-8507, Japan
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Osaka, Osaka, 530-8480, Japan
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Osaka, Osaka, 534-0021, Japan
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Osaka, Osaka, 537-8511, Japan
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Osaka, Osaka, 540-0006, Japan
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Osaka, Osaka, 543-8555, Japan
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Osaka, Osaka, 545-8586, Japan
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Osaka, Osaka, 558-8558, Japan
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Sayama, Osaka, 589-8511, Japan
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Suita, Osaka, 565-0871, Japan
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Izunokuni, Shizuoka, 410-2295, Japan
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Sunto, Shizuoka, 411-8777, Japan
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Shimotsuke, Tochigi, 329-0498, Japan
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Chuo-ku, Tokyo, 104-0045, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Meguro-ku, Tokyo, 152-8902, Japan
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Minato-ku, Tokyo, 105-8470, Japan
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Musashino, Tokyo, 180-8610, Japan
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Nerima-ku, Tokyo, 177-8521, Japan
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Shinjuku-ku, Tokyo, 160-0023, Japan
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Yonago, Tottori, 683-8504, Japan
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Toyama, Toyama, 930-8550, Japan
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Yamagata, Yamagata, 990-9585, Japan
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Shimonoseki, Yamaguchi, 750-0061, Japan
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Ube, Yamaguchi, 755-8505, Japan
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Chūō, Yamanashi, 409-3898, Japan
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Seoul, Seoul Teugbyeolsi, 152-703, South Korea
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Daegu, 700-721, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110-744, South Korea
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Seoul, 135710, South Korea
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Seoul, 138-736, South Korea
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Seoul, South Korea
Related Publications (1)
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.
PMID: 21664811RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer HealthCare AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
June 29, 2007
Study Start
April 1, 2006
Primary Completion
July 1, 2009
Study Completion
November 1, 2010
Last Updated
December 20, 2013
Results First Posted
January 20, 2011
Record last verified: 2013-11