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.
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
3 other identifiers
interventional
16
7 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 1, 2010
CompletedDecember 11, 2014
November 1, 2014
1.2 years
May 14, 2008
September 10, 2010
November 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival
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 Outcomes (4)
Response Rate
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Time to Progression
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Duration of Response
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Overall Survival
From start of treatment of the first subject until 14 months later, assessed every 8 Weeks
Study Arms (2)
Sorafenib (Nexavar, BAY43-9006)
EXPERIMENTALSorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously.
Sorafenib (Nexavar, BAY43-9006) + Interferon
EXPERIMENTALSorafenib 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.
Interventions
Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously
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 Criteria
You may qualify if:
- 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%).
You may not qualify if:
- Patient should be excluded if they have unresolved chronic toxicity grade
- \> 1 and related to prior therapy with sunitinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (35)
Unknown Facility
Vienna, Vienna, 1090, Austria
Unknown Facility
Salzburg, 5020, Austria
Unknown Facility
Avignon, 84000, France
Unknown Facility
Bayonne, 64100, France
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Marseille, 13015, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Nantes, 44020, France
Unknown Facility
Paris, 75014, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Reims, 51100, France
Unknown Facility
Strasbourg, 67000, France
Unknown Facility
Toulouse, 31052, France
Unknown Facility
Vandœuvre-lès-Nancy, 54000, France
Unknown Facility
Dublin, Dublin, 24, Ireland
Unknown Facility
Cork, Ireland
Unknown Facility
Aviano, Pordenone, 33081, Italy
Unknown Facility
Legnago, Verona, 37045, Italy
Unknown Facility
Napoli, 80131, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Perugia, 06156, Italy
Unknown Facility
Reggio Emilia, 42100, Italy
Unknown Facility
Gdansk, 80-219, Poland
Unknown Facility
Lublin, 20-090, Poland
Unknown Facility
Warsaw, 04-141, Poland
Unknown Facility
Wroclaw, 50 - 556, Poland
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28046, Spain
Unknown Facility
Oviedo, Oviedo, 33006, Spain
Unknown Facility
Pamplona, Pamplona, 31008, Spain
Unknown Facility
Valencia, Valencia, 46009, Spain
Unknown Facility
London, London, SW3 6JJ, United Kingdom
Unknown Facility
Northwood, Middlesex, HA6 2RN, United Kingdom
Unknown Facility
Newcastle upon Tyne, Tyne and Wear, NE4 6BE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early by the Sponsor due to low accrual. No efficacy analyses were performed.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2008
First Posted
May 15, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
December 11, 2014
Results First Posted
October 1, 2010
Record last verified: 2014-11