drugset / Trial / NCT00281125

Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer

NCT00281125

Phase 1/2 Terminated 20 enrolled Nevada Cancer Institute
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2). This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.

Timeline

Start
2006-01
Primary completion
2006-09
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified Intravenous
Subject vatalanib Small molecule 750 mg Oral
Background Pemetrexed Small molecule

Indications