Long-term Extension From RCC Phase II (11515)
Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma
1 other identifier
interventional
95
1 country
41
Brief Summary
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2005
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
February 2, 2010
CompletedDecember 13, 2013
November 1, 2013
2.5 years
December 21, 2007
October 8, 2009
November 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Secondary Outcomes (5)
Best Tumor Response
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Overall Survival (OS)
From start of treatment of the first subject until 45 months later, assessed every 3 months
Overall Response Duration
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Time to Objective Response
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Overall Disease Control
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Study Arms (1)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALSorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Interventions
Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
Eligibility Criteria
You may qualify if:
- 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
- Patients who are willing to continue the study drug,
- Patients for whom the investigator consider continuation of the study drug is appropriate
- Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
- 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
- \. 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.
You may not qualify if:
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
- Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (41)
Unknown Facility
Akita, Akita, 010-8543, Japan
Unknown Facility
Asahi, Chiba, 289-2511, Japan
Unknown Facility
Chiba, Chiba, 260-8677, Japan
Unknown Facility
Chiba, Chiba, 260-8717, Japan
Unknown Facility
Matsuyama, Ehime, 791-0280, Japan
Unknown Facility
Fukuoka, Fukuoka, 812-0033, Japan
Unknown Facility
Fukuoka, Fukuoka, 812-8582, Japan
Unknown Facility
Kurume, Fukuoka, 830-0011, Japan
Unknown Facility
Isesaki, Gunma, 372-0817, Japan
Unknown Facility
Maebashi, Gunma, 371-8511, Japan
Unknown Facility
Sapporo, Hokkaido, 003-0804, Japan
Unknown Facility
Sapporo, Hokkaido, 060-8543, Japan
Unknown Facility
Sapporo, Hokkaido, 060-8648, Japan
Unknown Facility
Sunagawa, Hokkaido, 073-0196, Japan
Unknown Facility
Tsukuba, Ibaraki, 305-8576, Japan
Unknown Facility
Morioka, Iwate, 020-8505, Japan
Unknown Facility
Kagoshima, Kagoshima-ken, 890-8520, Japan
Unknown Facility
Kyoto, Kyoto, 602-8566, Japan
Unknown Facility
Kyoto, Kyoto, 606-8507, Japan
Unknown Facility
Tsu, Mie-ken, 514-8507, Japan
Unknown Facility
Natori-shi, Miyagi, 981-1293, Japan
Unknown Facility
Kashihara, Nara, 634-8522, Japan
Unknown Facility
Kurashiki, Okayama-ken, 710-8602, Japan
Unknown Facility
Okayama, Okayama-ken, 700-8558, Japan
Unknown Facility
Osaka, Osaka, 537-8511, Japan
Unknown Facility
Sayama, Osaka, 589-8511, Japan
Unknown Facility
Suita, Osaka, 565-0871, Japan
Unknown Facility
Hidaka, Saitama, 350-1298, Japan
Unknown Facility
Irima-gun, Saitama, 350-0495, Japan
Unknown Facility
Tokorozawa, Saitama, 359-8513, Japan
Unknown Facility
Hamamatsu, Shizuoka, 431-3192, Japan
Unknown Facility
Sunto, Shizuoka, 411-8777, Japan
Unknown Facility
Utsunomiya, Tochigi, 320-0834, Japan
Unknown Facility
Tokushima, Tokushima, 770-8503, Japan
Unknown Facility
Arakawa-ku, Tokyo, 116-8567, Japan
Unknown Facility
Bunkyo-ku, Tokyo, 113-8655, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0045, Japan
Unknown Facility
Itabashi-ku, Tokyo, 173-0003, Japan
Unknown Facility
Shinjuku-ku, Tokyo, 162-8666, Japan
Unknown Facility
Yamagata, Yamagata, 990-9585, Japan
Unknown Facility
Ube, Yamaguchi, 755-8505, Japan
Related Publications (1)
Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11.
PMID: 21481133RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 4, 2008
Study Start
December 1, 2005
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
December 13, 2013
Results First Posted
February 2, 2010
Record last verified: 2013-11