Status:
TERMINATED
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.
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 the...
Eligibility Criteria
Inclusion
- 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
- Patient should be excluded if they have unresolved chronic toxicity grade
- \> 1 and related to prior therapy with sunitinib.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00678288
Start Date
April 1 2008
End Date
June 1 2009
Last Update
December 11 2014
Active Locations (35)
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1
Vienna, Vienna, Austria, 1090
2
Salzburg, Austria, 5020
3
Avignon, France, 84000
4
Bayonne, France, 64100