drugset / Trial / NCT00408226

Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer

NCT00408226

Phase 1/2 Completed 27 enrolled CASI pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS"), of oral MKC-1, administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer (NSCLC).

Timeline

Start
2006-10
Primary completion
2009-06
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject MKC-1 Small molecule Oral
Background Pemetrexed Small molecule 500 mg/m2 Intravenous