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. - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00678288

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 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.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Sorafenib (Nexavar, BAY43-9006)	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate Sorafenib Sorafenib tosylate Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Bayer:

Primary Outcome Measures:

Progression-Free Survival before dose escalation [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate, time to progression, duration of response and overall survival [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sorafenib (Nexavar, BAY43-9006) Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
Arm 2: Experimental	Drug: Sorafenib (Nexavar, BAY43-9006) 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Disease progression as defined by 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
MSKCC prognostic score low or intermediate
ECOG Performance Status of 0 or1
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678288

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Austria
	Not yet recruiting
Wien, Austria, 1090
France
	Not yet recruiting
BORDEAUX, France, 33000
	Recruiting
BAYONNE, France, 64100
	Not yet recruiting
VANDOEUVRE LES NANCY, France, 54000
	Recruiting
Reims, France, 51100
	Not yet recruiting
NANTES, France, 44020
	Recruiting
PARIS, France, 75674
	Recruiting
Avignon, France, 84000
	Recruiting
PARIS, France, 75634
	Not yet recruiting
MARSEILLE, France, 13005
	Not yet recruiting
STRASBOURG, France, 67000
	Not yet recruiting
MARSEILLE, France, 13915
Ireland
	Not yet recruiting
Cork, Ireland
	Not yet recruiting
Dublin, Ireland, 24
Italy
	Not yet recruiting
Perugia, Italy, 06156
	Recruiting
Pavia, Italy, 27100
	Not yet recruiting
Napoli, Italy, 80131
	Not yet recruiting
Reggio Emilia, Italy, 42100
Italy, Pordenone
	Recruiting
Aviano, Pordenone, Italy, 33081
Poland
	Recruiting
Lublin, Poland, 20-090
	Recruiting
Wroclaw, Poland, 50 - 556
	Recruiting
Gdansk, Poland, 80-210
	Recruiting
Warszawa, Poland, 00-909
Spain
	Recruiting
Barcelona, Spain, 08035
	Recruiting
Madrid, Spain, 28041
	Not yet recruiting
Madrid, Spain, 28007
	Not yet recruiting
Valencia, Spain, 46009
Spain, Asturias
	Not yet recruiting
Oviedo, Asturias, Spain, 33006
United Kingdom, Greater London
	Recruiting
London, Greater London, United Kingdom, SW3 6JJ
United Kingdom, Middlesex
	Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12782, EudraCT: 2007-005083-28
Study First Received:	May 14, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00678288
Health Authority:	Italy: The Italian Medicines Agency; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Federal Office for Safety in Health Care; Greece: National Organization of Medicines; Ireland: Irish Medicines Board

Keywords provided by Bayer:

Renal Cell Cancer
Interferon

Study placed in the following topic categories:

Interferon-alpha
Interferons
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Sunitinib

Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Interferon Alfa-2a
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009