drugset / Trial / NCT00290771

Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)

NCT00290771

Phase 2 Terminated 231 enrolled Novartis
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the survival rate at 12 and 24 months.

Timeline

Start
2006-02
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified 500 mg Oral
Subject Imatinib Small molecule 500 mg Oral
Subject Imatinib Small molecule 600 mg Oral

Indications