drugset / Trial / NCT00251589

A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

NCT00251589

Phase 1/2 Terminated 23 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Timeline

Start
2006-01
Primary completion
2007-10
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg
Subject Vorinostat Small molecule 200 mg Oral
Subject Vorinostat Small molecule 300 mg Oral
Subject Vorinostat Small molecule 400 mg Oral