An Open-Label Pharmacodynamic Study of Bevacivumab and Pazopanib in Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title: An Open-Label Study to Investigate the Pharmacodynamics of a Repeat Dose Regimen of Bevacizumab (10 mg/kg q2w) and Escalating Repeat Doses of Pazopanib in Renal Cell Carcinoma

Status Completed

Clinical Trial Summary

This study will determine whether blood tests, tumour imaging and tumour tissue analysis can reveal effects of drugs that block blood vessel growth (angiogenesis) in patients with renal cancer.

Clinical Trial Description

This single-centre, two-part, open-label study is designed to evaluate pharmacodynamic (PD) effects of bevacizumab and pazopanib in subjects with renal cancer who experience disease progression following at least one prior therapy of documented clinical benefit. In Part I, subjects will receive 3 infusions of 10 mg/kg bevacizumab, administered at 2-week intervals. The PD response to bevacizumab will be evaluated over 6 weeks using imaging techniques (magnetic resonance imaging; computed tomography [CT]; and positron emission tomography), intratumoural VEGF signaling by immunohistochemisty, plasma and serum biomarkers, and circulating tumour cells. Subjects may continue into Part II if, in the opinion of the investigator, the subject would derive continued clinical benefit from anti-angiogenic therapy. In Part II, each subject will receive sequentially escalating doses of oral pazopanib in 3-week cycles as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg daily, 4) 400 mg daily, 5) 800 mg daily, and 6) 1200 mg daily. Subjects entering Part II will be randomised to receive treatment either throughout each 3-week cycle (Group 1) or for the first 2 weeks of each cycle only, followed by a 1 week treatment holiday (Group 2). After completion of Part II dose escalation subjects will receive continuous pazopanib at a dose of 800 mg daily in repeating 3-week cycles. These subjects will receive pazopanib until loss of clinical benefit, death, unacceptable toxicity, or withdrawal from the study for other reasons. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

• NCT number: NCT00992121
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: November 18, 2009
• Completion date: November 1, 2013