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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

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

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

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
Primary Completion Date : June 2007
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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

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


  Show 320 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00111020     History of Changes
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:
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
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs