drugset / Trial / NCT00612651

PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas

NCT00612651

Phase 1 Completed 37 enrolled Duke University Schering-Plough · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Objectives: To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when administered w TEMODAR®. To characterize any toxicity associated w combo of farnesyl transferase inhibitor, SCH 66336, \& TEMODAR®. To observe patients for clinical antitumor response when treated with combination of farnesyl transferase inhibitor, SCH 66336, \& TEMODAR®. To assess pharmacokinetics of SCH 66336 for patients on \& not on enzyme inducing antiepileptic drugs.

Timeline

Start
2005-10
Primary completion
2009-01
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lonafarnib Small molecule 75 mg Oral
Subject Lonafarnib Small molecule 125 mg Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral