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Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: November 19, 2003   Last Updated: October 1, 2009   History of Changes
Sponsor: Bayer
Collaborator: ONYX Pharmaceuticals
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00073307
  Purpose

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY 43-9006)
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Till the end of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate Progression-free Survival (PFS) [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
  • To evaluate the best overall response rate [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
  • To assess changes in the patient's health-related quality of life [ Time Frame: every 6 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: No ]
  • Safety - (Adverse event assessment, Vital signs, Laboratory values) [ Time Frame: every 3 weeks for the first 24 weeks then every 4 weeks thereafter during treatment period ] [ Designated as safety issue: Yes ]
  • Safety - Electrocardiogram (ECG) [ Time Frame: Screening Visit and End of Treatment Visit ] [ Designated as safety issue: Yes ]

Enrollment: 905
Study Start Date: November 2003
Estimated Study Completion Date: October 2009
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 2: Placebo Comparator Drug: Placebo
Placebo
Arm 1: Experimental Drug: Sorafenib (Nexavar, BAY 43-9006)
Multi Kinase Inhibitor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
  • Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

  • Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
  • Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
  • Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Patients with a history or presence of metastatic brain or meningeal tumors
  • Patients with seizure disorder requiring medication (such as anti-epileptics)
  • History of organ allograft or bone marrow transplant of stem cell rescue
  • Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
  • Patients who have three or more of the following:

    1. ECOG performance status greater than or equal to 2,
    2. Abnormally high lactate dehydrogenase,
    3. Abnormally high serum hemoglobin,
    4. Abnormally high corrected serum calcium,
    5. Absence of prior nephrectomy

Excluded therapies and medications, previous and concomitant:

  • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
  • Significant surgery with 4 weeks of start of study
  • Investigational drug therapy during or within 30 days
  • Concomitant treatment with rifampin or St. John's Wort
  • Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
  • Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073307

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85712
United States, California
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90089
Davis, California, United States, 95616
United States, Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Lafayette, Louisiana, United States, 70506
United States, Maryland
Frederick, Maryland, United States, 21701
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Columbia, Missouri, United States, 65212-0001
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10032
Brooklyn, New York, United States, 11219
Bronx, New York, United States, 10466-2604
United States, Ohio
Cleveland, Ohio, United States, 44195
Dayton, Ohio, United States, 45429
Canton, Ohio, United States, 44718
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107-5096
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Laredo, Texas, United States, 78041
Dallas, Texas, United States, 75246
San Antonio, Texas, United States, 78212
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Richmond, Virginia, United States, 23294
United States, Washington
Seattle, Washington, United States, 98101
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226-3596
Argentina
Mendoza, Argentina, 5500
Santa Fé, Argentina, S3000FFV
Argentina, Capital Federal
Buenos Aires, Capital Federal, Argentina, C1426ANZ
Argentina, Santa Fe
Rosario, Santa Fe, Argentina, S2000DSK
Australia, Australian Capital Territory
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Sydney, New South Wales, Australia, 2145
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
Wodonga, Victoria, Australia, 0390
Belgium
BRUXELLES, Belgium, 1090
BRUXELLES, Belgium, 1000
Brazil, PR
Curitiba, PR, Brazil, 81520-060
Brazil, Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90619900
Brazil, RS
Porto Alegre, RS, Brazil, 90470 340
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Hamilton, Ontario, Canada, L8V 5C2
London, Ontario, Canada, N6A 4L6
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Chile
Santiago, Chile, 838-0456
France
SAINT HERBLAIN, France, 44805
CAEN CEDEX 5, France, 14076
PARIS CEDEX 15, France, 75908
BORDEAUX, France, 33000
TOULOUSE, France, 31052
LILLE CEDEX, France, 59020
LYON CEDEX, France, 69008
VILLEJUIF CEDEX, France, 94305
MARSEILLE, France, 13273
STRASBOURG, France, 67091
Germany
Berlin, Germany, 10967
Hamburg, Germany, 20251
Germany, Baden-Württemberg
Ulm, Baden-Württemberg, Germany, 89075
Mannheim, Baden-Württemberg, Germany, 68167
Germany, Bayern
Regensburg, Bayern, Germany, 93053
München, Bayern, Germany, 81377
Germany, Hessen
Darmstadt, Hessen, Germany, 64276
Frankfurt, Hessen, Germany, 60488
Germany, Nordrhein-Westfalen
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Germany, Sachsen
Dresden, Sachsen, Germany, 01307
Hungary
Debrecen, Hungary, 4032
Budapest, Hungary, 1121
Budapest, Hungary, 1032
Zalaegerszeg, Hungary, 8900
Israel
Haifa, Israel, 31096
Tel Aviv, Israel, 64239
Italy
Roma, Italy, 00128
Reggio Emilia, Italy, 42100
Pavia, Italy, 27100
Modena, Italy, 41124
Perugia, Italy, 06122
Milano, Italy, 20133
Netherlands
NIJMEGEN, Netherlands, 6525 GA
Poland
Warszawa, Poland, 02-781
Wroclaw, Poland, 50-367
Szczecin, Poland, 70-111
Lublin, Poland, 20-090
Poznan, Poland, 61-701
Gdansk, Poland, 80-210
Lodz, Poland, 93-509
Krakow, Poland, 31-115
Warszawa, Poland, 00-909
Russian Federation
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 115478
Kazan, Russian Federation, 420029
Barnaul, Russian Federation, 656049
St. Petersburg, Russian Federation, 198255
Kirov, Russian Federation, 610021
Russian Federation, Kaluga region
Obninsk, Kaluga region, Russian Federation, 249036
South Africa, Free State
Bloemfontein, Free State, South Africa, 9300
South Africa, GAUTENG
Pretoria, GAUTENG, South Africa
South Africa, Kwazulu Natal
Durban, Kwazulu Natal, South Africa, 4001
South Africa, Western Cape
Cape Town, Western Cape, South Africa, 7505
Spain
Barcelona, Spain, 08035
Madrid, Spain, 28040
Valencia, Spain, 46009
Spain, Bizkaia
Barakaldo, Bizkaia, Spain, 48903
Ukraine
Poltava, Ukraine, 36024
Kharkiv, Ukraine, 61024
Kiev, Ukraine, 115
Lviv, Ukraine, 79031
Donetsk, Ukraine, 83092
United Kingdom, Greater Manchester
Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Middlesex
Northwood, Middlesex, United Kingdom, HA6 2RN
United Kingdom, South Glamorgan
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
United Kingdom, Strathclyde
Glasgow, Strathclyde, United Kingdom, G11 6NT
United Kingdom, Surrey
Sutton, Surrey, United Kingdom, SM2 5PT
United Kingdom, Tyne and Wear
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 5BE
United Kingdom, West Midlands
Birmingham, West Midlands, United Kingdom, B15 2TT
Sponsors and Collaborators
Bayer
ONYX Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers: 11213
Study First Received: November 19, 2003
Last Updated: October 1, 2009
ClinicalTrials.gov Identifier: NCT00073307     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Renal Cell Cancer (RCC)
Cancer

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009