Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

January 8, 2014 updated by: Bayer

A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overall Survival (OS), Patient-reported outcome (PRO)

Study Type

Interventional

Enrollment (Actual)

903

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal-Buenos Aires, Argentina, C1426ANZ
      • Mendoza, Argentina, 5500
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSK
      • Santa Fé, Santa Fe, Argentina, S3000FFV
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Liverpool, New South Wales, Australia, 2170
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
      • Wodonga, Victoria, Australia, 0390
  • Belgium
      • Bruxelles - Brussel, Belgium, 1000
      • Bruxelles - Brussel, Belgium, 1090
  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 81520-060
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90619900
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-060
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
      • London, Ontario, Canada, N6A 4L6
      • Toronto, Ontario, Canada, M5G 2M9
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Chile
      • Santiago de Chile, Chile
  • France
      • Bordeaux, France, 33000
      • Caen Cedex 5, France, 14076
      • Lille Cedex, France, 59020
      • Lyon Cedex, France, 69008
      • Marseille, France, 13273
      • Nantes, France, 44805
      • Paris Cedex 15, France, 75908
      • Strasbourg, France, 67091
      • Toulouse, France, 31052
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 10967
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
      • Ulm, Baden-Württemberg, Germany, 89075
    • Bayern
      • München, Bayern, Germany, 81377
      • Regensburg, Bayern, Germany, 93042
    • Hessen
      • Darmstadt, Hessen, Germany, 64276
      • Frankfurt, Hessen, Germany, 60488
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
  • Hungary
      • Budapest, Hungary, 1121
      • Budapest, Hungary, 1032
      • Debrecen, Hungary, 4004
      • Zalaegerszeg, Hungary, 8900
  • Israel
      • Haifa, Israel, 3109601
      • Tel Aviv, Israel, 64239
  • Italy
      • Milano, Italy, 20133
      • Modena, Italy, 41124
      • Pavia, Italy, 27100
      • Perugia, Italy, 06122
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00144
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
  • Poland
      • Gdansk, Poland, 80-210
      • Krakow, Poland, 31-115
      • Lodz, Poland, 93-509
      • Lublin, Poland, 20-090
      • Poznan, Poland, 61-878
      • Szczecin, Poland, 70-111
      • Warszawa, Poland, 02-781
      • Warszawa, Poland, 04-141
      • Wroclaw, Poland, 50-043
  • Russian Federation
      • Barnaul, Russian Federation, 656049
      • Kazan, Russian Federation, 420029
      • Kirov, Russian Federation, 610021
      • Moscow, Russian Federation, 125284
      • Moscow, Russian Federation, 115478
      • Obninsk, Russian Federation, 249036
      • St. Petersburg, Russian Federation, 198255
  • South Africa
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9300
    • Gauteng
      • Pretoria, Gauteng, South Africa
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4001
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28040
      • Valencia, Spain, 46009
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spain, 48903
  • Ukraine
      • Donetsk, Ukraine, 83092
      • Kharkiv, Ukraine, 61024
      • Kiev, Ukraine, 115
      • Lviv, Ukraine, 79031
      • Poltava, Ukraine, 36024
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G11 6NT
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
    • California
      • Los Angeles, California, United States, 90033
      • Los Angeles, California, United States, 90057
      • Sacramento, California, United States, 95817
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • Hamden, Connecticut, United States, 06518
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
    • Maryland
      • Frederick, Maryland, United States, 21701
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • Columbia, Missouri, United States, 65203-3244
      • St. Louis, Missouri, United States, 63110-1093
    • New York
      • Bronx, New York, United States, 10466-2604
      • Brooklyn, New York, United States, 11220
      • New York, New York, United States, 10032
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cleveland, Ohio, United States, 44195
      • Dayton, Ohio, United States, 45429
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5096
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Texas
      • Dallas, Texas, United States, 75246
      • Laredo, Texas, United States, 78041
      • San Antonio, Texas, United States, 78212
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Richmond, Virginia, United States, 23229
    • Washington
      • Seattle, Washington, United States, 98101
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    • ECOG performance status greater than or equal to 2,
    • Abnormally high lactate dehydrogenase,
    • Abnormally high serum hemoglobin,
    • Abnormally high corrected serum calcium,
    • Absence of prior nephrectomy

  • Excluded therapies and medications, previous and concomitant:

    • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Drug: Sorafenib (Nexavar, BAY43-9006)
Multi Kinase Inhibitor
Placebo Comparator: Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Progression-Free Survival (PFS) - Independent Radiological Review
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Best Overall Response - Independent Radiological Review
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
Time Frame: From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 19, 2003

First Submitted That Met QC Criteria

November 20, 2003

First Posted (Estimate)

November 21, 2003

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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