drugset / Trial / NCT00611689
Imatinib and PTK787/ZK222584 in Refractory and/or Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |