A Study to Assess Sorafenib Alone and in Combination With Low-Dose Interferon Following Unsuccessful Treatment With Sunitinib in Patients With Advanced Renal Cell Cancer.

November 24, 2014 updated by: Bayer

A Phase II, Randomized, Open-label, Multicenter, Study Evaluating the Efficacy of Sorafenib Alone and Sorafenib in Combination With Low Dose Interferon Alpha-2a as Second-line Treatment of Sunitinib Failure in Patients With Metastatic Renal Cell Carcinoma

This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

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

  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1090
  • France
      • Avignon, France, 84000
      • Bayonne, France, 64100
      • Bordeaux, France, 33000
      • Marseille, France, 13385
      • Marseille, France, 13015
      • Nantes, France, 44020
      • Paris, France, 75014
      • Paris, France, 75651
      • Reims, France, 51100
      • Strasbourg, France, 67000
      • Toulouse, France, 31052
      • Vandoeuvre Les Nancy, France, 54000
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland, 24
  • Italy
      • Napoli, Italy, 80131
      • Pavia, Italy, 27100
      • Perugia, Italy, 06156
      • Reggio Emilia, Italy, 42100
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
    • Verona
      • Legnago, Verona, Italy, 37045
  • Poland
      • Gdansk, Poland, 80-219
      • Lublin, Poland, 20-090
      • Warszawa, Poland, 04-141
      • Wroclaw, Poland, 50 - 556
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Oviedo, Spain, 33006
      • Pamplona, Spain, 31008
      • Valencia, Spain, 46009
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 6BE

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:

  • Disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment)
  • And/or patients who have discontinued sunitinib treatment at any point due to toxicity
  • Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks
  • Memorial Sloane Kettering Cancer Centre (MSKCC) prognostic score low or intermediate
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%).

Exclusion Criteria:

  • Patient should be excluded if they have unresolved chronic toxicity grade
  • > 1 and related to prior therapy with sunitinib.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
Experimental: Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.
Drug: Sorafenib (Nexavar, BAY43-9006) + Interferon
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation.
From start of treatment of the first subject until 14 months later, assessed every 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Time to Progression
Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Duration of Response
Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact.
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Overall Survival
Time Frame: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks

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

April 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12782
  • 2007-005083-28 (EudraCT Number)
  • CONCERT (Other Identifier: Bayer)

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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