An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell Carcinoma

December 26, 2014 updated by: Bayer

An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

Purpose of the study:

The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib.

Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment.

Overall, participation in the study will help determine the following:

  • Find out if patients receiving Sorafenib will live longer
  • Find out if Sorafenib helps to slow the worsening of kidney cancer
  • Find out if Sorafenib has an effect on the tumours

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1150

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

  • Belgium
      • Bruxelles - Brussel, Belgium, 1000
      • Leuven, Belgium, 3000
  • Denmark
      • Århus C, Denmark, 8000
  • France
      • Bordeaux, France, 33000
      • Lyon Cedex, France, 69008
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 12200
      • Hamburg, Germany, 20251
    • Bayern
      • München, Bayern, Germany, 81377
    • Hessen
      • Darmstadt, Hessen, Germany, 64276
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
  • Italy
      • Milano, Italy, 20133
      • Modena, Italy, 41124
      • Pavia, Italy, 27100
      • Perugia, Italy, 06156
      • Reggio Emilia, Italy, 42100
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
  • Poland
      • Warszawa, Poland, 04-141
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28040
    • Asturias
      • Oviedo, Asturias, Spain, 33006
  • Sweden
      • Göteborg, Sweden, 413 45
      • Stockholm, Sweden, 171 76
  • Switzerland
      • Genève, Switzerland, 1211
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G11 6NT
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT

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:

  • The patient must provide written informed consent prior to receiving BAY 43-9006
  • The male or female patient must be at least 18 years of age
  • The patient must have advanced Renal Cell Carcinoma
  • The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC
  • A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry
  • The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates while taking BAY 43-9006
  • Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with sorafenib
  • For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks)

Exclusion Criteria:

  • Patients who are currently enrolled in or have previously participated in any other sorafenib trial
  • Patients, who are eligible for or do have access to any other sorafenib clinical trial as to the knowledge of the Investigator
  • Patients who have a life expectancy of less than 2 months
  • Patients with metastatic brain or meningeal tumors
  • Patients are excluded who require any of the following:
  • Investigational drug therapy during the treatment with sorafenib or within 30 days prior to their first dose of sorafenib
  • Concomitant Rifampicin
  • Concomitant St. John's Wort (Hypericum perforatum) Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time (PT) should be performed (please note that no laboratory data are collected in this study)
  • Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study)
  • Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
  • Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45-0.47 second)
  • Patients with active coronary artery disease or ischemia
  • Patients with Child-Pugh class C hepatic impairment
  • Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis
  • Patients with active uncontrolled hypertension
  • Patients with recent or active bleeding diathesis
  • Patients with any medical condition which could jeopardize their safety while taking an investigational drug

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Nexavar (Sorafenib, BAY43-9006)
Multikinase inhibitor: Sorafenib mono therapy 400 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Parameters
Time Frame: Continously
Continously

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection of radiological evaluations
Time Frame: Continously
Continously

Collaborators and Investigators

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

Sponsor

Bayer

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.

Helpful Links

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

October 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11941
  • 2005-002524-34 (EudraCT Number)

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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