NCT00611793

PTK787/ZK222584 With Bevacizumab in Patients With Refractory and/or Advanced Malignancies

A Phase I Trial of PTK787/ZK222584 in Combination With Bevacizumab (Avastin) in Patients With Refractory and/or Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PTK787/ZK222584 is an orally active inhibitor of VEGF-R tyrosine kinases. Bevacizumab is an intravenous humanized monoclonal antibody directed against vascular endothelial growth factor. By binding to VEGF, bevacizumab blocks VEGF-A receptor binding. Due to the different mechanisms of action and the non-overlapping toxicity profiles of the two agents, it is hoped that a combination regimen incorporating both compounds will produce increased activity without enhanced toxicity.

Conditions

• Refractory Malignancy
• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	PTK787/ZK222584 and Bevacizumab	PTK787/ZK222584 will be administered as a single agent orally on days 1-14 of cycle 1. The day 14 dose of PTK787/ZK222584 will be administered in the outpatient clinic and PK samples will be obtained. On Day 15 the patient will receive the initial dose of IV bevacizumab and PTK787/ZK222584. Bevacizumab will be repeated at 2 week intervals in patients with stable disease or better for four cycles of treatment (16 weeks). After four treatment cycles, only patients with a PR or CR will continue treatment with PTK787/ZK222584 and bevacizumab. Patients with stable disease may continue single agent PTK787/ZK22258 from cycle 5 onward. Protocol treatment will continue until disease progression or intolerable toxicity warrants drug discontinuation.

Timeline

• Start date: 2004-10-01
• Primary completion: 2008-01-01
• Completion: 2009-01-01
• First posted: 2008-02-11
• Last updated: 2009-01-23

Locations

1 site across 1 country: United States