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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00111020
First received: May 16, 2005
Last updated: August 5, 2014
Last verified: August 2014

May 16, 2005
August 5, 2014
June 2005
June 2007   (final data collection date for primary outcome measure)
Safety parameters [ Time Frame: From signing consent to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00111020 on ClinicalTrials.gov Archive Site
Limited radiological evaluations [ Time Frame: At baseline, than every 8 weeks after start of sorafenib ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Renal Cell
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
Experimental: Arm 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
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. doi: 10.1002/cncr.24864.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2567
October 2008
June 2007   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00111020
11868
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
August 2014

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