Trial Condition(s):

Carcinoma, Renal Cell

BAY43-9006 Phase II study for Renal cell carcinoma

Bayer Identifier:

11515

ClinicalTrials.gov Identifier:

NCT00661375

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- More than three regimens of previous treatment for RCC

Trial Summary

Enrollment Goal
131
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Sapporo City General Hospital

Sapporo, Japan, 060-8604

Locations

Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Locations

Sunagawa City Medical Center

Sunagawa, Japan, 073-0196

Locations

Akita University Hospital

Akita, Japan, 010-8543

Locations

National Cancer Center Central Hospital

Tokyo, Japan, 104-0045

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Keio University Hospital

Tokyo, Japan, 160-8582

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Tokyo Women's Medical University Hospital

Tokyo, Japan, 162-8666

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Nippon Medical School Hospital

Tokyo, Japan, 113-8603

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Tokyo Women's Medical University Medical Center East

Tokyo, Japan, 116-8567

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Chiba Cancer Center

Chiba, Japan, 260-0801

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Chiba University Hospital

Chiba, Japan, 260-8677

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Saitama Medical School Hospital

Irima-gun, Japan, 350-0495

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Isesaki Municipal Hospital

Isesaski, Japan, 372-0817

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Tochigi Cancer Center

Utsunomiya, Japan, 320-0834

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Tsukuba University Hospital

Tsukuba, Japan, 305-8576

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Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

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Hokkaido University Hospital

Sapporo, Japan, 060-8648

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Iwate Medical University Hospital

Morioka, Japan, 020-8505

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Tohoku University Hospital

Sendai, Japan, 980-8574

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Miyagi Cancer Center

Natori, Japan, 981-1293

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Yamagata University Hospital

Yamagata, Japan, 990-9585

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University of Tokyo Hospital

Tokyo, Japan, 113-8655

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Teikyo University Hospital

Tokyo, Japan, 173-0003

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Asahi Central Hospital

Asahi, Japan, 289-2511

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National Defense Medical College Hospital

Tokorozawa, Japan, 359-8513

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Gunma University Hospital

Maebashi, Japan, 371-8511

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Nagoya University Hospital

Nagoya, Japan, 466-8560

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Niigata University Medical and Dental Hospital

Niigata, Japan, 951-8520

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Osaka University Hospital

Suita, Japan, 565-0871

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Kyoto Medical University Hospital

Kyoto, Japan, 602-8566

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Hamamatsu University Hospital

Hamamatsu, Japan, 431-3192

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Shizuoka Cancer Center

Sunto, Japan, 411-8777

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University of Yamanashi Hospital

Nakakoma, Japan, 409-3898

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Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan, 537-8511

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Kinki University Hospital

Osakasayama, Japan, 589-8511

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Kyoto University Hospital

Kyoto, Japan, 606-8507

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Mie University Hospital

Tsu, Japan, 514-8507

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Kurashiki Central Hospital

Kurashiki, Japan, 710-8602

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Yamaguchi University Hospital

Ube, Japan, 755-8505

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Tokushima University Hospital

Tokushima, Japan, 770-8503

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Kagawa University Hospital

Kita, Japan, 761-0793

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Kyushu University Hospital

Fukuoka, Japan, 812-8582

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Harasanshin Hospital

Fukuoka, Japan, 812-0033

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Kurume University Hospital

Kurume, Japan, 830-0011

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Nagasaki University Hospital

Nagasaki, Japan, 852-8501

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Nara Medical University Hospital

Kashihara, Japan, 634-8522

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Japanese Red Cross Wakayama Medical center

Wakayama, Japan, 640-8558

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Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

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Okayama University Hospital

Okayama, Japan, 700-8558

Locations

Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Locations

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Trial Design