Long-term Extension From RCC Phase II (11515)

Study Overview
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Brief Summary
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Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

Official Title
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Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib (Nexavar, BAY43-9006)<br>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 | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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. | 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. | From start of treatment of the first subject until 45 months later, assessed every 8 weeks | 
| 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. | From start of treatment of the first subject until 45 months later, assessed every 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sorafenib, Nexavar, Metastatic RCC, Renal Cell Carcinoma, Unresectable RCC