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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
903

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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