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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111020
Recruitment Status : Completed
First Posted : May 17, 2005
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Sorafenib (Nexavar, BAY43-9006) Phase 3

Expanded Access : Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2567 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Study Start Date : June 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 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


Outcome Measures
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Primary Outcome Measures :
  1. Safety parameters [ Time Frame: From signing consent to 30 days after last dose of study drug ]

Secondary Outcome Measures :
  1. Limited radiological evaluations [ Time Frame: At baseline, than every 8 weeks after start of sorafenib ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111020


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00111020    
Other Study ID Numbers: 11868
First Posted: May 17, 2005    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action