BAY43-9006 Phase II Study for Renal Cell Carcinoma

Phase 2

Completed

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

• Registration Number: NCT00661375
• Lead Sponsor: Bayer

Brief Summary

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
• Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.

Exclusion Criteria

• More than three regimens of previous treatment for RCC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Nexavar (Sorafenib, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Tumor response rate	Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.

Secondary Outcome Measures

Name	Time	Method
Time to death	At the time of death
Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma	Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Overall disease control rate	Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Time to progression	Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
FACT-G and FKSI	Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.
Overall response duration and time to objective response	Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.