drugset / Trial / NCT00611689

Imatinib and PTK787/ZK222584 in Refractory and/or Advanced Solid Tumors

NCT00611689

NaSingle-groupOpen-labelTreatment

Summary

In this phase I study, the investigators will determine the maximum tolerated doses of imatinib and PTK/ZK administered in two different dose schedules. Due to the different mechanisms of action and the minimally-overlapping toxicity profiles of these two novel oral agents, it is hoped that a combination regimen incorporating both compounds will produce increased activity without enhanced toxicity. After completion of this phase I study, the investigators propose a follow-up phase II study in patients with previously treated metastatic renal cell cancer - where VEGF and PDGF appear to play important roles in the malignant phenotype - to determine the antitumor efficacy of the recommended dose of this combination regimen.

Timeline

Start
2004-07
Primary completion
2008-01
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg Oral
Subject Imatinib Small molecule 600 mg Oral
Subject vatalanib Small molecule 250 mg Oral
Subject vatalanib Small molecule 500 mg Oral
Subject vatalanib Small molecule 750 mg Oral
Subject vatalanib Small molecule 1000 mg Oral