Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00111020

Purpose

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 treatment or to placebo (sugar pill). All patients in this protocol will be treated with sorafenib, which will be provided free of charge during the course of this protocol. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

In the US, interested patients should ask their physicians to call: 1-866-639-2827 for more information.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Further study details as provided by Bayer:

Primary Outcome Measures:

Safety [ Time Frame: 31 Mar. 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Limited radiological evaluations [ Time Frame: 31 Mar. 2008 ] [ Designated as safety issue: No ]

Enrollment:	2622
Study Start Date:	June 2005
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, 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

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111020

Locations

Canada
Bayer Clinical Research Center
ask Contact, Canada

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11868
Study First Received:	May 16, 2005
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00111020
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms

Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009