Carcinoma, Renal Cell Clinical Trial
Official title:
Phase II Study of Pazopanib as Second-line Treatment After Sunitinib in Metastatic Renal Cell Carcinoma (mRCC) Patients
assess the activity and toxicity of second-line treatment with pazopanib after failure of first-line sunitinib treatment in patients with clear cell mRCC; to investigate the potential association of DLL4, Notch1, VEGFA, PDGFRB, HIF-1α and HIF-2α with clinical response to pazopanib in mRCC patients.
The primary end point was progression-free survival (PFS). Secondary end points were overall
survival (OS), objective response rate (ORR) and safety. We assessed the tumor response
according to the RECIST 1.1.
Efficacy was evaluated by computed tomography with contrast of the chest, abdomen, and
pelvis. We performed tumor assessments with the use of imaging studies at baseline and every
six weeks until the end of treatment. We also used such assessments to confirm a response (at
least 4 weeks after initial documentation) and whenever disease progression was suspected.
All imaging scans were evaluated by an independent imaging-review committee (IRC) blinded to
study treatment. Patients who had inadequate data for study assessment was regarded as
nonevaluable.
Adverse events were graded according to the Common Terminology Criteria for Adverse Events
(CTCAE) version 3.0. Safety was assessed by physical examination and laboratory tests.
Electrocardiograms (ECGs) were performed at baseline and every six weeks until the end of
treatment.
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