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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02324803
Study type Interventional
Source Southern China Urology Cancer Consortium
Contact Mian Xie
Phone 862083062956
Email mianxie@gird.cn
Status Unknown status
Phase Phase 2
Start date July 2014
Completion date December 2015

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