Long-term Extension From RCC Phase II (11515)

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00586495
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-04
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Results First Submitted: 2009-10-08
• Results First Submitted QC: 2010-01-12
• Results First Posted: 2010-02-02
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib (Nexavar, BAY43-9006)	Sorafenib (Nexavar, BAY43-9006)	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 Measures

Name	Time	Method
Progression Free Survival (PFS)	From start of treatment of the first subject until 45 months later, assessed every 8 weeks	Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).

Secondary Outcome Measures

Name	Time	Method
Best Tumor Response	From start of treatment of the first subject until 45 months later, assessed every 8 weeks	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)	From start of treatment of the first subject until 45 months later, assessed every 3 months	Time from initiation of treatment to death due to any cause.
Overall Response Duration	From start of treatment of the first subject until 45 months later, assessed every 8 weeks	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	From start of treatment of the first subject until 45 months later, assessed every 8 weeks	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	From start of treatment of the first subject until 45 months later, assessed every 8 weeks	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.