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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 466-8560 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21481133 | Background | 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. | |
| 21342228 |
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|
| 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. |
| FACT-G and FKSI | Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter. |
| Akita |
| Akita |
| 010-8543 |
| Japan |
| Asahi | Chiba | 289-2511 | Japan |
| Chiba | Chiba | 260-0801 | Japan |
| Chiba | Chiba | 260-8677 | Japan |
| Matsuyama | Ehime | 791-0280 | Japan |
| Fukuoka | Fukuoka | 812-0033 | Japan |
| Fukuoka | Fukuoka | 812-8582 | Japan |
| Kurume | Fukuoka | 830-0011 | Japan |
| Isesaski | Gunma | 372-0817 | Japan |
| Maebashi | Gunma | 371-8511 | Japan |
| Sapporo | Hokkaido | 003-0804 | Japan |
| Sapporo | Hokkaido | 060-8543 | Japan |
| Sapporo | Hokkaido | 060-8604 | Japan |
| Sapporo | Hokkaido | 060-8648 | Japan |
| Sunagawa | Hokkaido | 073-0196 | Japan |
| Tsukuba | Ibaraki | 305-8576 | Japan |
| Morioka | Iwate | 020-8505 | Japan |
| Kita | Kagawa-ken | 761-0793 | Japan |
| Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Kyoto | Kyoto | 602-8566 | Japan |
| Kyoto | Kyoto | 606-8507 | Japan |
| Tsu | Mie-ken | 514-8507 | Japan |
| Natori-shi | Miyagi | 981-1293 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Nagasaki | Nagasaki | 852-8501 | Japan |
| Kashihara | Nara | 634-8522 | Japan |
| Niigata | Niigata | 951-8520 | Japan |
| Kurashiki | Okayama-ken | 710-8602 | Japan |
| Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka | Osaka | 537-8511 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Suita | Osaka | 565-0871 | Japan |
| Irima-gun | Saitama | 350-0495 | Japan |
| Tokorozawa | Saitama | 359-8513 | Japan |
| Hamamatsu | Shizuoka | 431-3192 | Japan |
| Sunto | Shizuoka | 411-8777 | Japan |
| Utsunomiya | Tochigi | 320-0834 | Japan |
| Tokushima | Tokushima | 770-8503 | Japan |
| Wakayama | Wakayama | 640-8558 | Japan |
| Wakayama | Wakayama | 641-8510 | Japan |
| Yamagata | Yamagata | 990-9585 | Japan |
| Ube | Yamaguchi | 755-8505 | Japan |
| Nakakoma | Yamanashi | 409-3898 | Japan |
| Tokyo | 104-0045 | Japan |
| Tokyo | 113-8603 | Japan |
| Tokyo | 113-8655 | Japan |
| Tokyo | 116-8567 | Japan |
| Tokyo | 160-8582 | Japan |
| Tokyo | 162-8666 | Japan |
| Tokyo | 173-0003 | Japan |
| 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. |
| 17951335 | Result | 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. |
| 21467949 | Result | 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. |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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