Back to resultsLong-term Extension From RCC Phase II (11515)
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Sorafenib (Nexavar, BAY43-9006)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Sorafenib, Nexavar, Metastatic RCC, Renal Cell Carcinoma, Unresectable RCC
Eligibility Criteria
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
- 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
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sorafenib (Nexavar, BAY43-9006)
Arm Description
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
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
Secondary Outcome Measures
Best Tumor Response
Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Overall Survival (OS)
Time from initiation of treatment to death due to any cause.
Overall Response Duration
Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.
Time to Objective Response
Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.
Overall Disease Control
Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00586495
Brief Title
Long-term Extension From RCC Phase II (11515)
Official Title
Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Sorafenib, Nexavar, Metastatic RCC, Renal Cell Carcinoma, Unresectable RCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorafenib (Nexavar, BAY43-9006)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sorafenib (Nexavar, BAY43-9006)
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Secondary Outcome Measure Information:
Title
Best Tumor Response
Description
Best tumor response, including Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter) according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Title
Overall Survival (OS)
Description
Time from initiation of treatment to death due to any cause.
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 3 months
Title
Overall Response Duration
Description
Time from the date of first objective response (CR or PR, whichever is first recorded) to the date when progressive disease (PD, at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions) is first documented according to RECIST.
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Title
Time to Objective Response
Description
Time from initiation of treatment to the date when an objective response (CR or PR, whichever is first recorded) is first documented according to RECIST.
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Title
Overall Disease Control
Description
Subjects who have a best response rating of CR, PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started) per RECIST that is maintained for at least 28 days from the first demonstration of that rating.
Time Frame
From start of treatment of the first subject until 45 months later, assessed every 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
City
Isesaki
State/Province
Gunma
ZIP/Postal Code
372-0817
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
City
Sunagawa
State/Province
Hokkaido
ZIP/Postal Code
073-0196
Country
Japan
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
City
Natori
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
City
Irima-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-8567
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0003
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21481133
Citation
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.
Results Reference
result
Learn more about this trial
Long-term Extension From RCC Phase II (11515)
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