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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.

NCT ID: NCT00678288

Last Updated: 2014-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Keywords

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Renal Cell Cancer Interferon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.

Group Type EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously

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.

Group Type EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006) + Interferon

Intervention Type DRUG

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.

Interventions

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Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Vienna, Vienna, Austria

Site Status

Salzburg, , Austria

Site Status

Avignon, , France

Site Status

Bayonne, , France

Site Status

Bordeaux, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Nantes, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Reims, , France

Site Status

Strasbourg, , France

Site Status

Toulouse, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Dublin, Dublin, Ireland

Site Status

Cork, , Ireland

Site Status

Aviano, Pordenone, Italy

Site Status

Legnago, Verona, Italy

Site Status

Napoli, , Italy

Site Status

Pavia, , Italy

Site Status

Perugia, , Italy

Site Status

Reggio Emilia, , Italy

Site Status

Gdansk, , Poland

Site Status

Lublin, , Poland

Site Status

Warsaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Barcelona, Barcelona, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Oviedo, Oviedo, Spain

Site Status

Pamplona, Pamplona, Spain

Site Status

Valencia, Valencia, Spain

Site Status

London, London, United Kingdom

Site Status

Northwood, Middlesex, United Kingdom

Site Status

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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Austria France Ireland Italy Poland Spain United Kingdom

Related Links

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http://www.clinicaltrialsregister.eu

Click here and search for EudraCT infomation of Bayer Product

Other Identifiers

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2007-005083-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CONCERT

Identifier Type: OTHER

Identifier Source: secondary_id

12782

Identifier Type: -

Identifier Source: org_study_id