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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Paulmy - Bayonne BAYONNE, France, 64100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de Courlancy Reims Reims, France, 51100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego Wroclaw, Poland, 50 - 556 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzkie Centrum Onkologii Gdansk, Poland, 80-219 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Ziemi Lubelskiej Lublin, Poland, 20-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cochin - Paris PARIS, France, 75014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CLINIQUE SAINTE CATHERINE Avignon, France, 84000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Pitié-Salpétrière - Paris PARIS, France, 75651 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Centro di Riferimento Oncologico - CRO Aviano, Italy, 33081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newcastle General Hospital Newcastle Upon Tyne, United Kingdom, NE4 6BE | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CENTRE CATHERINE DE SIENNE NANTES, France, 44020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Alexis Vautrin - Vandoeuvre les Nancy VANDOEUVRE LES NANCY, France, 54000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Claudius Regaud - Toulouse TOULOUSE, France, 31052 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Timone - Marseille Marseille, France, 13385 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique de l'Orangerie STRASBOURG, France, 67000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital du Nord - Marseille MARSEILLE, France, 13015 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Perugia Perugia, Italy, 06156 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.R.N. Antonio Cardarelli Napoli, Italy, 80131 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 21 Legnago - Veneto Legnago, Italy, 37045 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Central de Asturias Oviedo, Spain, 33006 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Universitaria de Navarra Pamplona, Spain, 31008 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28046 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Landeskrankenhaus Salzburg Salzburg, Austria, 5020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tallaght Hospital Dublin, Ireland, 24 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bon Secours Hospital Cork, Ireland | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression-Free SurvivalTimeframe: From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Secondary Outcome
- Response RateTimeframe: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
- Time to ProgressionTimeframe: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
- Duration of ResponseTimeframe: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
- Overall SurvivalTimeframe: From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Additional Information
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