Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
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
Progression Free Survival (PFS)
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
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)
Time frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Overall Survival (OS)
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
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 frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
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.
Time frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Asahi, Chiba, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Isesaki, Gunma, Japan
Unnamed facility
Maebashi, Gunma, Japan
...and 31 more locations
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.
Time frame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks