check_circleStudy 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
  • 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.
  • 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
95
Trial Dates
December 2005 - July 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hokkaido Cancer CenterSapporo, 003-0804, Japan
Completed
Akita University HospitalAkita, 010-8543, Japan
Completed
Miyagi Cancer CenterNatori, 981-1293, Japan
Completed
National Cancer Center HospitalChuo-ku, 104-0045, Japan
Completed
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Completed
University of Tokyo HospitalBunkyo-ku, 113-8655, Japan
Completed
Tokyo Women's Medical University Medical Center EastArakawa-ku, 116-8567, Japan
Completed
Saitama Medical School HospitalIrima-gun, 350-0495, Japan
Completed
Isesaki Municipal HospitalIsesaki, 372-0817, Japan
Completed
Tochigi Cancer CenterUtsunomiya, 320-0834, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Mie University HospitalTsu, 514-8507, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Sapporo Medical University HospitalSapporo, 060-8543, Japan
Completed
Hokkaido University HospitalSapporo, 060-8648, Japan
Completed
Sunagawa City Medical CenterSunagawa, 073-0196, Japan
Completed
Iwate Medical University HospitalMorioka, 020-8505, Japan
Completed
Yamagata University HospitalYamagata, 990-9585, Japan
Completed
Teikyo University HospitalItabashi-ku, 173-0003, Japan
Completed
Chiba Cancer CenterChiba, 260-8717, Japan
Completed
Chiba University HospitalChiba, 260-8677, Japan
Completed
Asahi Central HospitalAsahi, 289-2511, Japan
Completed
National Defense Medical College HospitalTokorozawa, 359-8513, Japan
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
University of Tsukuba HospitalTsukuba, 305-8576, Japan
Completed
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Completed
Osaka Medical Center for Cancer and Cardiovascular DiseasesOsaka, 537-8511, Japan
Completed
Saitama Medical University International Medical CenterHidaka, 350-1298, Japan
Completed
Kinki University HospitalOsakasayama, 589-8511, Japan
Completed
Kyoto Medical University HospitalKyoto, 602-8566, Japan
Completed
Nara Medical University HospitalKashihara, 634-8522, Japan
Completed
Okayama University HospitalOkayama, 700-8558, Japan
Completed
Kurashiki Central HospitalKurashiki, 710-8602, Japan
Completed
Yamaguchi University HospitalUbe, 755-8505, Japan
Completed
Tokushima University HospitalTokushima, 770-8503, Japan
Completed
Shikoku Cancer CenterMatsuyama, 791-0280, Japan
Completed
Harasanshin HospitalFukuoka, 812-0033, Japan
Completed
Kagoshima University Medical and Dental HospitalKagoshima, 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 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Best Tumor Response
    date_rangeTime Frame:
    From start of treatment of the first subject until 45 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall Survival (OS)
    date_rangeTime Frame:
    From start of treatment of the first subject until 45 months later, assessed every 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Overall Response Duration
    date_rangeTime Frame:
    From start of treatment of the first subject until 45 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to Objective Response
    date_rangeTime Frame:
    From start of treatment of the first subject until 45 months later, assessed every 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall Disease Control
    date_rangeTime Frame:
    From start of treatment of the first subject until 45 months later, assessed every 8 weeks
    enhanced_encryption
    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
1

Additional Information

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