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

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
Status
LocationsStatus
Locations

Sapporo City General Hospital

Sapporo, Japan, 060-8604

Status
Completed
 
Locations

Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Status
Completed
 
Locations

Sunagawa City Medical Center

Sunagawa, Japan, 073-0196

Status
Completed
 
Locations

Akita University Hospital

Akita, Japan, 010-8543

Status
Completed
 
Locations

National Cancer Center Central Hospital

Tokyo, Japan, 104-0045

Status
Completed
 
Locations

Keio University Hospital

Tokyo, Japan, 160-8582

Status
Completed
 
Locations

Tokyo Women's Medical University Hospital

Tokyo, Japan, 162-8666

Status
Completed
 
Locations

Nippon Medical School Hospital

Tokyo, Japan, 113-8603

Status
Completed
 
Locations

Tokyo Women's Medical University Medical Center East

Tokyo, Japan, 116-8567

Status
Completed
 
Locations

Chiba Cancer Center

Chiba, Japan, 260-0801

Status
Completed
 
Locations

Chiba University Hospital

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Saitama Medical School Hospital

Irima-gun, Japan, 350-0495

Status
Completed
 
Locations

Isesaki Municipal Hospital

Isesaski, Japan, 372-0817

Status
Completed
 
Locations

Tochigi Cancer Center

Utsunomiya, Japan, 320-0834

Status
Completed
 
Locations

Tsukuba University Hospital

Tsukuba, Japan, 305-8576

Status
Completed
 
Locations

Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

Status
Completed
 
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

Iwate Medical University Hospital

Morioka, Japan, 020-8505

Status
Completed
 
Locations

Tohoku University Hospital

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Miyagi Cancer Center

Natori, Japan, 981-1293

Status
Completed
 
Locations

Yamagata University Hospital

Yamagata, Japan, 990-9585

Status
Completed
 
Locations

University of Tokyo Hospital

Tokyo, Japan, 113-8655

Status
Completed
 
Locations

Teikyo University Hospital

Tokyo, Japan, 173-0003

Status
Completed
 
Locations

Asahi Central Hospital

Asahi, Japan, 289-2511

Status
Completed
 
Locations

National Defense Medical College Hospital

Tokorozawa, Japan, 359-8513

Status
Completed
 
Locations

Gunma University Hospital

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Nagoya University Hospital

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Niigata University Medical and Dental Hospital

Niigata, Japan, 951-8520

Status
Completed
 
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

Kyoto Medical University Hospital

Kyoto, Japan, 602-8566

Status
Completed
 
Locations

Hamamatsu University Hospital

Hamamatsu, Japan, 431-3192

Status
Completed
 
Locations

Shizuoka Cancer Center

Sunto, Japan, 411-8777

Status
Completed
 
Locations

University of Yamanashi Hospital

Nakakoma, Japan, 409-3898

Status
Completed
 
Locations

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan, 537-8511

Status
Completed
 
Locations

Kinki University Hospital

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Mie University Hospital

Tsu, Japan, 514-8507

Status
Completed
 
Locations

Kurashiki Central Hospital

Kurashiki, Japan, 710-8602

Status
Completed
 
Locations

Yamaguchi University Hospital

Ube, Japan, 755-8505

Status
Completed
 
Locations

Tokushima University Hospital

Tokushima, Japan, 770-8503

Status
Completed
 
Locations

Kagawa University Hospital

Kita, Japan, 761-0793

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Harasanshin Hospital

Fukuoka, Japan, 812-0033

Status
Completed
 
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Completed
 
Locations

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Nara Medical University Hospital

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Japanese Red Cross Wakayama Medical center

Wakayama, Japan, 640-8558

Status
Completed
 
Locations

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Status
Completed
 
Locations

Okayama University Hospital

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Kagoshima University Hospital

Kagoshima, Japan, 890-8520

Status
Completed
 

Trial Design