Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Activity and Safety of Second Line SOrafenib After Pazopanib in Patients With Metastatic Renal Cell Carcinoma (SOAP Study)
- Retrospective studies showed Sorafenib's efficacy as second line treatment after a
Tyrosine Kinase Inhibitor (TKI).
- Currently there is no standard of treatment in 2nd line for patients treated in first
line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).
- With this trial we evaluate the efficacy of sorafenib as second line of treatment in
patients treated with pazopanib for mRCC.
- Retrospective studies showed Sorafenib's efficacy as second line treatment after a TKI:
AXIS study showed sorafenib activity, in terms of Overall Response Rate (ORR), and the
absence statistically significant difference in Overall Survival (OS) between the 2
arms, although there is a significant OS increase of 1.4 months in the Axitinib arm. The
INTORSECT study (temsirolimus vs sorafenib in 2nd line after sunitinib) didn't
demonstrate statistically significant difference for Progression Free Survival (PFS),
but it showed an OS increase in patients treated with sorafenib.
- The COMPARZ study demonstrated the non-inferiority of pazopanib vs sunitinib in 1st line
of treatment for mRCC.
- Currently there is no standard of treatment in 2nd line for patients treated in first
line with pazopanib for mRCC.
- Primary objective:to evaluate the efficacy of sorafenib (PFS) as second line of
treatment in patients treated with pazopanib for mRCC.
- Secondary objectives: To evaluate the safety of sorafenib in patients previously treated
with pazopanib. To evaluate the Overall Survival. To evaluate the Quality of Life
through specific questionnaires (FKSI-19; European Organization for Research and
Treatment of Cancer quality of life questionnaire -C30).To assess the predictive role
for PFS and OS of arterial blood pressure increase from baseline to week 4 and 8 after
start of treatment with sorafenib. To assess the predictive role for PFS and OS of
hand-foot syndrome before week 4 and 8 after start of treatment with sorafenib.
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