Study Completed

Carcinoma, Renal Cell

Bayer Identifier:

12056

ClinicalTrials.gov Identifier:

NCT00586495

EudraCT Number:

Not Available

EU CT Number:

Not Available

Long-term extension from RCC Phase II (11515)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years

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

December 2005 - July 2008

Phase

Phase 2

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Hokkaido Cancer Center	Sapporo, 003-0804, Japan
Completed	Akita University Hospital	Akita, 010-8543, Japan
Completed	Miyagi Cancer Center	Natori, 981-1293, Japan
Completed	National Cancer Center Hospital	Chuo-ku, 104-0045, Japan
Completed	Tokyo Women's Medical University Hospital	Shinjuku-ku, 162-8666, Japan
Completed	University of Tokyo Hospital	Bunkyo-ku, 113-8655, Japan
Completed	Tokyo Women's Medical University Medical Center East	Arakawa-ku, 116-8567, Japan
Completed	Saitama Medical School Hospital	Irima-gun, 350-0495, Japan
Completed	Isesaki Municipal Hospital	Isesaki, 372-0817, Japan
Completed	Tochigi Cancer Center	Utsunomiya, 320-0834, Japan
Completed	Osaka University Hospital	Suita, 565-0871, Japan
Completed	Kyoto University Hospital	Kyoto, 606-8507, Japan
Completed	Mie University Hospital	Tsu, 514-8507, Japan
Completed	Kyushu University Hospital	Fukuoka, 812-8582, Japan
Completed	Kurume University Hospital	Kurume, 830-0011, Japan
Completed	Sapporo Medical University Hospital	Sapporo, 060-8543, Japan
Completed	Hokkaido University Hospital	Sapporo, 060-8648, Japan
Completed	Sunagawa City Medical Center	Sunagawa, 073-0196, Japan
Completed	Iwate Medical University Hospital	Morioka, 020-8505, Japan
Completed	Yamagata University Hospital	Yamagata, 990-9585, Japan
Completed	Teikyo University Hospital	Itabashi-ku, 173-0003, Japan
Completed	Chiba Cancer Center	Chiba, 260-8717, Japan
Completed	Chiba University Hospital	Chiba, 260-8677, Japan
Completed	Asahi Central Hospital	Asahi, 289-2511, Japan
Completed	National Defense Medical College Hospital	Tokorozawa, 359-8513, Japan
Completed	Gunma University Hospital	Maebashi, 371-8511, Japan
Completed	University of Tsukuba Hospital	Tsukuba, 305-8576, Japan
Completed	Hamamatsu University Hospital	Hamamatsu, 431-3192, Japan
Completed	Shizuoka Cancer Center	Sunto, 411-8777, Japan
Completed	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka, 537-8511, Japan
Completed	Saitama Medical University International Medical Center	Hidaka, 350-1298, Japan
Completed	Kinki University Hospital	Osakasayama, 589-8511, Japan
Completed	Kyoto Medical University Hospital	Kyoto, 602-8566, Japan
Completed	Nara Medical University Hospital	Kashihara, 634-8522, Japan
Completed	Okayama University Hospital	Okayama, 700-8558, Japan
Completed	Kurashiki Central Hospital	Kurashiki, 710-8602, Japan
Completed	Yamaguchi University Hospital	Ube, 755-8505, Japan
Completed	Tokushima University Hospital	Tokushima, 770-8503, Japan
Completed	Shikoku Cancer Center	Matsuyama, 791-0280, Japan
Completed	Harasanshin Hospital	Fukuoka, 812-0033, Japan
Completed	Kagoshima University Medical and Dental Hospital	Kagoshima, 890-8520, Japan

Primary Outcome

Progression Free Survival (PFS)
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Safety Issue:
No

Secondary Outcome

Best Tumor Response
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Safety Issue:
No
Overall Survival (OS)
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 3 months
Safety Issue:
No
Overall Response Duration
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Safety Issue:
No
Time to Objective Response
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Safety Issue:
No
Overall Disease Control
Time Frame:
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Safety Issue:
No

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

Additional Information

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