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
PHASE2
95 participants
INTERVENTIONAL
2005-12-31
2008-07-31
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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Sorafenib (Nexavar, BAY43-9006)
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Eligibility Criteria
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Inclusion Criteria
Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
Population II: Patients who have been monitored only for survival status at the end of Study 11515.
Population 1
1. Patients who are willing to continue the study drug,
2. Patients for whom the investigator consider continuation of the study drug is appropriate
3. Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
4. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Population 2
1\. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria
2. Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
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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Akita, Akita, Japan
Asahi, Chiba, Japan
Chiba, Chiba, Japan
Chiba, Chiba, Japan
Matsuyama, Ehime, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kurume, Fukuoka, Japan
Isesaki, Gunma, Japan
Maebashi, Gunma, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sunagawa, Hokkaido, Japan
Tsukuba, Ibaraki, Japan
Morioka, Iwate, Japan
Kagoshima, Kagoshima-ken, Japan
Kyoto, Kyoto, Japan
Kyoto, Kyoto, Japan
Tsu, Mie-ken, Japan
Natori-shi, Miyagi, Japan
Kashihara, Nara, Japan
Kurashiki, Okayama-ken, Japan
Okayama, Okayama-ken, Japan
Osaka, Osaka, Japan
Sayama, Osaka, Japan
Suita, Osaka, Japan
Hidaka, Saitama, Japan
Irima-gun, Saitama, Japan
Tokorozawa, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Sunto, Shizuoka, Japan
Utsunomiya, Tochigi, Japan
Tokushima, Tokushima, Japan
Arakawa-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Yamagata, Yamagata, Japan
Ube, Yamaguchi, 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.
Other Identifiers
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12056
Identifier Type: -
Identifier Source: org_study_id