NCT00753246

Nimotuzumab in Adults With Glioblastoma Multiforma

Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Oncoscience AG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Determination of efficiency of nimotuzumab in adults with glioblastoma multiforma

Detailed description

The objective of the present study is a comparison of treatment of patients with newly diagnosed glioblastoma multiforme grade IV. Patients will be randomized in one of two arms when included. Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy. Patients randomised in arm B will receive standard radiotherapy plus Temozolomide treatment.

Conditions

• Adults With Glioblastoma Multiforma

Interventions

Type	Name	Description
DRUG	nimotuzumab	monoclonal antibody

Timeline

• Start date: 2007-08-01
• Completion: 2012-01-01
• First posted: 2008-09-16
• Last updated: 2012-12-03

Locations

1 site across 1 country: Germany