Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2004-11-30
2006-03-31
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Nexavar (Sorafenib, BAY43-9006)
BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.
Interventions
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Nexavar (Sorafenib, BAY43-9006)
BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.
Eligibility Criteria
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Inclusion Criteria
* Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.
Exclusion Criteria
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
Akita, Akita, Japan
Asahi, Chiba, Japan
Chiba, Chiba, Japan
Chiba, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kurume, Fukuoka, Japan
Isesaski, Gunma, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sunagawa, Hokkaido, Japan
Tsukuba, Ibaraki, Japan
Morioka, Iwate, Japan
Kita, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kyoto, Kyoto, Japan
Kyoto, Kyoto, Japan
Tsu, Mie-ken, Japan
Natori-shi, Miyagi, Japan
Sendai, Miyagi, Japan
Nagasaki, Nagasaki, Japan
Kashihara, Nara, Japan
Niigata, Niigata, Japan
Kurashiki, Okayama-ken, Japan
Okayama, Okayama-ken, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Suita, Osaka, Japan
Irima-gun, Saitama, Japan
Tokorozawa, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Sunto, Shizuoka, Japan
Utsunomiya, Tochigi, Japan
Tokushima, Tokushima, Japan
Wakayama, Wakayama, Japan
Wakayama, Wakayama, Japan
Yamagata, Yamagata, Japan
Ube, Yamaguchi, Japan
Nakakoma, Yamanashi, Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Countries
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References
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Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11.
Iijima M, Fukino K, Adachi M, Tsukamoto T, Murai M, Naito S, Minami H, Furuse J, Akaza H. Sorafenib-associated hand-foot syndrome in Japanese patients. J Dermatol. 2011 Mar;38(3):261-6. doi: 10.1111/j.1346-8138.2010.01059.x. Epub 2010 Nov 2.
Akaza H, Tsukamoto T, Murai M, Nakajima K, Naito S. Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Jpn J Clin Oncol. 2007 Oct;37(10):755-62. doi: 10.1093/jjco/hym095. Epub 2007 Oct 19.
Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.
Other Identifiers
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11515
Identifier Type: -
Identifier Source: org_study_id