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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
continuous treatment of 800 mg pazopanib once daily until disease progression
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGprogression-free survival (PFS)
Time frame: pazopanib treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled
Overall survival of patients treated with second-line pazopanib therapy
Time frame: Initiation of pazopanib dose until death, assessed up to 30 months after the last patient has been enrolled
Objective Response Rate to pazopanib therapy
Time frame: Initiation of pazopanib treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled
Number of grade 3 or 4 adverse events attributable to pazopanib
Time frame: Time of first dose of pazopanib to approximately one month after discontinuation of pazopanib
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