NCT02029573

Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: King Fahad Medical City · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of Atorvastatin in combination with multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).The anticipated time on study treatment is until disease progression, and the target sample size is 32 individuals.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Atorvastatin	80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)
DRUG	Temozolomide	75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
RADIATION	Radiotherapy	60 Gy in 30 fractions

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2014-01-08
• Last updated: 2017-08-18

Locations

1 site across 1 country: Saudi Arabia