drugset / Trial / NCT00768911

CT-322 in Combination With Radiation Therapy and Temozolomide to Treat Newly Diagnosed Glioblastoma Multiforme

NCT00768911

Phase 1 Unknown 30 enrolled Adnexus, A Bristol-Myers Squibb R&D Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Rationale: In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable to postulate that adding these agents to standard RT and chemotherapy in the up-front management of newly diagnosed GBM may improve the clinical benefit. This study will examine the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide (RT/TMZ) backbone of treatment for newly diagnosed GBM

Timeline

Start
2008-10
Primary completion
2010-10
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PEGDINETANIB Protein / enzyme biologic 0.5 mg/kg Intravenous
Subject PEGDINETANIB Protein / enzyme biologic 1 mg/kg Intravenous
Subject PEGDINETANIB Protein / enzyme biologic 2 mg/kg Intravenous
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications