Trial Condition(s):

Carcinoma, Renal Cell

Long-term extension from RCC Phase II (11515)

Bayer Identifier:

12056

ClinicalTrials.gov Identifier:

NCT00586495

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

Inclusion Criteria
Patients are classified into two groups as below at transition date from Study 11515 to this study.  
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
1. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
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.

Trial Summary

Enrollment Goal
95
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

Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Status
Completed
 
Locations

Akita University Hospital

Akita, Japan, 010-8543

Status
Completed
 
Locations

Miyagi Cancer Center

Natori, Japan, 981-1293

Status
Completed
 
Locations

National Cancer Center Hospital

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Tokyo Women's Medical University Hospital

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

University of Tokyo Hospital

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Tokyo Women's Medical University Medical Center East

Arakawa-ku, Japan, 116-8567

Status
Completed
 
Locations

Saitama Medical School Hospital

Irima-gun, Japan, 350-0495

Status
Completed
 
Locations

Isesaki Municipal Hospital

Isesaki, Japan, 372-0817

Status
Completed
 
Locations

Tochigi Cancer Center

Utsunomiya, Japan, 320-0834

Status
Completed
 
Locations

Osaka University Hospital

Suita, Japan, 565-0871

Status
Completed
 
Locations

Kyoto University Hospital

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Mie University Hospital

Tsu, Japan, 514-8507

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Completed
 
Locations

Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

Status
Completed
 
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

Sunagawa City Medical Center

Sunagawa, Japan, 073-0196

Status
Completed
 
Locations

Iwate Medical University Hospital

Morioka, Japan, 020-8505

Status
Completed
 
Locations

Yamagata University Hospital

Yamagata, Japan, 990-9585

Status
Completed
 
Locations

Teikyo University Hospital

Itabashi-ku, Japan, 173-0003

Status
Completed
 
Locations

Chiba Cancer Center

Chiba, Japan, 260-8717

Status
Completed
 
Locations

Chiba University Hospital

Chiba, Japan, 260-8677

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

University of Tsukuba Hospital

Tsukuba, Japan, 305-8576

Status
Completed
 
Locations

Hamamatsu University Hospital

Hamamatsu, Japan, 431-3192

Status
Completed
 
Locations

Shizuoka Cancer Center

Sunto, Japan, 411-8777

Status
Completed
 
Locations

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Japan, 537-8511

Status
Completed
 
Locations

Saitama Medical University International Medical Center

Hidaka, Japan, 350-1298

Status
Completed
 
Locations

Kinki University Hospital

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Kyoto Medical University Hospital

Kyoto, Japan, 602-8566

Status
Completed
 
Locations

Nara Medical University Hospital

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Okayama University Hospital

Okayama, Japan, 700-8558

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

Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Harasanshin Hospital

Fukuoka, Japan, 812-0033

Status
Completed
 
Locations

Kagoshima University Medical and Dental Hospital

Kagoshima, Japan, 890-8520

Status
Completed
 

Trial Design