Trial Condition(s):

Carcinoma, Renal Cell

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.

Bayer Identifier:

12782

ClinicalTrials.gov Identifier:

NCT00678288

EudraCT Number:

2007-005083-28

Terminated/Withdrawn

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
16
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Clinique Paulmy - Bayonne

BAYONNE, France, 64100

Status
Completed
 
Locations

Clinique de Courlancy Reims

Reims, France, 51100

Status
Completed
 
Locations

Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141

Status
Completed
 
Locations

Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Poland, 50 - 556

Status
Completed
 
Locations

Wojewodzkie Centrum Onkologii

Gdansk, Poland, 80-219

Status
Completed
 
Locations

Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland, 20-090

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Cochin - Paris

PARIS, France, 75014

Status
Completed
 
Locations

CLINIQUE SAINTE CATHERINE

Avignon, France, 84000

Status
Completed
 
Locations

Hôpital de la Pitié-Salpétrière - Paris

PARIS, France, 75651

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

IRCCS Centro di Riferimento Oncologico - CRO

Aviano, Italy, 33081

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Newcastle General Hospital

Newcastle Upon Tyne, United Kingdom, NE4 6BE

Status
Terminated
 
Locations

CENTRE CATHERINE DE SIENNE

NANTES, France, 44020

Status
Terminated
 
Locations

Centre Alexis Vautrin - Vandoeuvre les Nancy

VANDOEUVRE LES NANCY, France, 54000

Status
Terminated
 
Locations

Institut Claudius Regaud - Toulouse

TOULOUSE, France, 31052

Status
Terminated
 
Locations

Hôpital de la Timone - Marseille

Marseille, France, 13385

Status
Terminated
 
Locations

Clinique de l'Orangerie

STRASBOURG, France, 67000

Status
Terminated
 
Locations

Hôpital du Nord - Marseille

MARSEILLE, France, 13015

Status
Terminated
 
Locations

A.O.U. di Perugia

Perugia, Italy, 06156

Status
Terminated
 
Locations

A.O.R.N. Antonio Cardarelli

Napoli, Italy, 80131

Status
Terminated
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Terminated
 
Locations

AULSS 21 Legnago - Veneto

Legnago, Italy, 37045

Status
Terminated
 
Locations

Hospital Central de Asturias

Oviedo, Spain, 33006

Status
Terminated
 
Locations

Clínica Universitaria de Navarra

Pamplona, Spain, 31008

Status
Terminated
 
Locations

Instituto Valenciano de Oncología

Valencia, Spain, 46009

Status
Terminated
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28046

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Terminated
 
Locations

Landeskrankenhaus Salzburg

Salzburg, Austria, 5020

Status
Terminated
 
Locations

Tallaght Hospital

Dublin, Ireland, 24

Status
Terminated
 
Locations

Bon Secours Hospital

Cork, Ireland

Status
Terminated
 

Trial Design