drugset / Trial / NCT00335075

Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)

NCT00335075

Phase 3 Completed 151 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.

Timeline

Start
2005-03-02
Primary completion
2006-02-23
Completion
2006-02-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Semustine Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 150 mg/m2 Oral
Subject Temozolomide Small molecule 200 mg/m2 Oral