Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00111020

First received: May 16, 2005

Last updated: June 29, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2005

Last Updated Date

June 29, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety parameters [ Time Frame: From signing consent to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00111020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Limited radiological evaluations [ Time Frame: At baseline, than every 8 weeks after start of sorafenib ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Official Title ^ICMJE

Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Brief Summary

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY 43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Renal Cell

Intervention ^ICMJE

Drug: Sorafenib (Nexavar, BAY43-9006)

Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)

Publications *

Stadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2567

Completion Date

October 2008

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with advanced (unresectable, recurrent or metastatic) RCC
Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
Patients with an ECOG performance status of 0-2
Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

Exclusion Criteria:

Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
Patients who have participated in any other sorafenib trial
Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
Life expectancy of less than two months
Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
Patients with active coronary artery disease or ischemia
Patients with Child-Pugh class C hepatic impairment
Patients with severe renal impairment or who require dialysis
Patients with active uncontrolled hypertension
Patients with recent or active bleeding diathesis

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00111020

Other Study ID Numbers ^ICMJE

11868

Has Data Monitoring Committee

Responsible Party

Bayer HealthCare Pharmaceuticals Inc., Therapeutic Area Head

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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