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
18 Years
N/A
Both
Carcinoma, Renal Cell
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival
Outcome Description:
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.
Outcome Time Frame:
From start of treatment of the first subject until 14 months later, assessed every 8 weeks
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Italy: The Italian Medicines Agency
Study ID:
12782
NCT ID:
NCT00678288
Start Date:
April 2008
Completion Date:
June 2009
Related Keywords:
- Carcinoma, Renal Cell
- Renal Cell Cancer
- Interferon
- Carcinoma
- Carcinoma, Renal Cell
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