BAY43-9006 Phase II Study for Renal Cell Carcinoma
Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma
1 other identifier
interventional
131
1 country
51
Brief Summary
To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2004
Shorter than P25 for phase_2
51 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
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedDecember 25, 2014
December 1, 2014
1.3 years
April 4, 2008
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor response rate
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Secondary Outcomes (6)
Time to progression
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Time to death
At the time of death
Overall response duration and time to objective response
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Overall disease control rate
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
- +1 more secondary outcomes
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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
You may qualify if:
- Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
- 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.
You may not qualify if:
- More than three regimens of previous treatment for RCC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (51)
Unknown Facility
Nagoya, Aichi-ken, 466-8560, Japan
Unknown Facility
Akita, Akita, 010-8543, Japan
Unknown Facility
Asahi, Chiba, 289-2511, Japan
Unknown Facility
Chiba, Chiba, 260-0801, Japan
Unknown Facility
Chiba, Chiba, 260-8677, Japan
Unknown Facility
Matsuyama, Ehime, 791-0280, Japan
Unknown Facility
Fukuoka, Fukuoka, 812-0033, Japan
Unknown Facility
Fukuoka, Fukuoka, 812-8582, Japan
Unknown Facility
Kurume, Fukuoka, 830-0011, Japan
Unknown Facility
Isesaski, Gunma, 372-0817, Japan
Unknown Facility
Maebashi, Gunma, 371-8511, Japan
Unknown Facility
Sapporo, Hokkaido, 003-0804, Japan
Unknown Facility
Sapporo, Hokkaido, 060-8543, Japan
Unknown Facility
Sapporo, Hokkaido, 060-8604, Japan
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Sapporo, Hokkaido, 060-8648, Japan
Unknown Facility
Sunagawa, Hokkaido, 073-0196, Japan
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Tsukuba, Ibaraki, 305-8576, Japan
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Morioka, Iwate, 020-8505, Japan
Unknown Facility
Kita, Kagawa-ken, 761-0793, Japan
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Kagoshima, Kagoshima-ken, 890-8520, Japan
Unknown Facility
Kyoto, Kyoto, 602-8566, Japan
Unknown Facility
Kyoto, Kyoto, 606-8507, Japan
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Tsu, Mie-ken, 514-8507, Japan
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Natori-shi, Miyagi, 981-1293, Japan
Unknown Facility
Sendai, Miyagi, 980-8574, Japan
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Nagasaki, Nagasaki, 852-8501, Japan
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Kashihara, Nara, 634-8522, Japan
Unknown Facility
Niigata, Niigata, 951-8520, Japan
Unknown Facility
Kurashiki, Okayama-ken, 710-8602, Japan
Unknown Facility
Okayama, Okayama-ken, 700-8558, Japan
Unknown Facility
Osaka, Osaka, 537-8511, Japan
Unknown Facility
Sayama, Osaka, 589-8511, Japan
Unknown Facility
Suita, Osaka, 565-0871, Japan
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Irima-gun, Saitama, 350-0495, Japan
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Tokorozawa, Saitama, 359-8513, Japan
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Hamamatsu, Shizuoka, 431-3192, Japan
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Sunto, Shizuoka, 411-8777, Japan
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Utsunomiya, Tochigi, 320-0834, Japan
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Tokushima, Tokushima, 770-8503, Japan
Unknown Facility
Wakayama, Wakayama, 640-8558, Japan
Unknown Facility
Wakayama, Wakayama, 641-8510, Japan
Unknown Facility
Yamagata, Yamagata, 990-9585, Japan
Unknown Facility
Ube, Yamaguchi, 755-8505, Japan
Unknown Facility
Nakakoma, Yamanashi, 409-3898, Japan
Unknown Facility
Tokyo, 104-0045, Japan
Unknown Facility
Tokyo, 113-8603, Japan
Unknown Facility
Tokyo, 113-8655, Japan
Unknown Facility
Tokyo, 116-8567, Japan
Unknown Facility
Tokyo, 160-8582, Japan
Unknown Facility
Tokyo, 162-8666, Japan
Unknown Facility
Tokyo, 173-0003, Japan
Related Publications (4)
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.
PMID: 21481133BACKGROUNDIijima 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.
PMID: 21342228RESULTAkaza 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.
PMID: 17951335RESULTKatakami 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.
PMID: 21467949RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 18, 2008
Study Start
November 1, 2004
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
December 25, 2014
Record last verified: 2014-12