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

Trial Dates

December2005

July2008

Phase

Could I receive a placebo?

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Hokkaido Cancer Center Sapporo, Japan, 003-0804	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Akita University Hospital Akita, Japan, 010-8543	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Miyagi Cancer Center Natori, Japan, 981-1293	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations University of Tokyo Hospital Bunkyo-ku, Japan, 113-8655	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tokyo Women's Medical University Medical Center East Arakawa-ku, Japan, 116-8567	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Saitama Medical School Hospital Irima-gun, Japan, 350-0495	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Isesaki Municipal Hospital Isesaki, Japan, 372-0817	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tochigi Cancer Center Utsunomiya, Japan, 320-0834	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Osaka University Hospital Suita, Japan, 565-0871	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kyoto University Hospital Kyoto, Japan, 606-8507	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Mie University Hospital Tsu, Japan, 514-8507	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kurume University Hospital Kurume, Japan, 830-0011	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Sunagawa City Medical Center Sunagawa, Japan, 073-0196	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Iwate Medical University Hospital Morioka, Japan, 020-8505	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Yamagata University Hospital Yamagata, Japan, 990-9585	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Teikyo University Hospital Itabashi-ku, Japan, 173-0003	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Chiba Cancer Center Chiba, Japan, 260-8717	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Chiba University Hospital Chiba, Japan, 260-8677	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Asahi Central Hospital Asahi, Japan, 289-2511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations National Defense Medical College Hospital Tokorozawa, Japan, 359-8513	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Gunma University Hospital Maebashi, Japan, 371-8511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations University of Tsukuba Hospital Tsukuba, Japan, 305-8576	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Hamamatsu University Hospital Hamamatsu, Japan, 431-3192	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka, Japan, 537-8511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kinki University Hospital Osakasayama, Japan, 589-8511	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kyoto Medical University Hospital Kyoto, Japan, 602-8566	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Okayama University Hospital Okayama, Japan, 700-8558	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kurashiki Central Hospital Kurashiki, Japan, 710-8602	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Yamaguchi University Hospital Ube, Japan, 755-8505	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Tokushima University Hospital Tokushima, Japan, 770-8503	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Shikoku Cancer Center Matsuyama, Japan, 791-0280	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Harasanshin Hospital Fukuoka, Japan, 812-0033	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Kagoshima University Medical and Dental Hospital Kagoshima, Japan, 890-8520	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

Extension study for BAY43-9006 in Japanese patients with Renal cell carcinoma

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Non-randomized

Blinding:

Open Label

Assignment:

Single Group Assignment

Trial Arms:

Primary Outcome

Progression Free Survival (PFS)
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Secondary Outcome

Best Tumor Response
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Overall Survival (OS)
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 3 months

Overall Response Duration
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Time to Objective Response
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Overall Disease Control
Timeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks

Carcinoma, Renal Cell

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information