check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
12056
ClinicalTrials.gov Identifier:
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
BothAge
18 YearsTrial summary
Enrollment Goal
95Trial Dates
December 2005 - July 2008Phase
Phase 2Could I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere 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)date_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Best Tumor Responsedate_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
- Overall Survival (OS)date_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 3 monthsenhanced_encryptionNoSafety Issue:
- Overall Response Durationdate_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
- Time to Objective Responsedate_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
- Overall Disease Controldate_rangeTime Frame:From start of treatment of the first subject until 45 months later, assessed every 8 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1