Trial Condition(s):
Carcinoma, Renal Cell
Long-term extension from RCC Phase II (11515)
Bayer Identifier:
12056
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hokkaido Cancer Center Sapporo, Japan, 003-0804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akita University Hospital Akita, Japan, 010-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miyagi Cancer Center Natori, Japan, 981-1293 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tokyo Hospital Bunkyo-ku, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Medical Center East Arakawa-ku, Japan, 116-8567 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Medical School Hospital Irima-gun, Japan, 350-0495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isesaki Municipal Hospital Isesaki, Japan, 372-0817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tochigi Cancer Center Utsunomiya, Japan, 320-0834 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mie University Hospital Tsu, Japan, 514-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunagawa City Medical Center Sunagawa, Japan, 073-0196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iwate Medical University Hospital Morioka, Japan, 020-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teikyo University Hospital Itabashi-ku, Japan, 173-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba Cancer Center Chiba, Japan, 260-8717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba University Hospital Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asahi Central Hospital Asahi, Japan, 289-2511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Defense Medical College Hospital Tokorozawa, Japan, 359-8513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tsukuba Hospital Tsukuba, Japan, 305-8576 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamamatsu University Hospital Hamamatsu, Japan, 431-3192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka, Japan, 537-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinki University Hospital Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto Medical University Hospital Kyoto, Japan, 602-8566 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurashiki Central Hospital Kurashiki, Japan, 710-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamaguchi University Hospital Ube, Japan, 755-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokushima University Hospital Tokushima, Japan, 770-8503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shikoku Cancer Center Matsuyama, Japan, 791-0280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harasanshin Hospital Fukuoka, Japan, 812-0033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagoshima University Medical and Dental Hospital Kagoshima, Japan, 890-8520 | 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:
1
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 ResponseTimeframe: 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 DurationTimeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
- Time to Objective ResponseTimeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
- Overall Disease ControlTimeframe: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Additional Information
Copyright © Bayer
Powered by
