NCT00597493

Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM

Phase 2 Study of Sorafenib Plus Protracted Temozolomide in Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PURPOSE AND OBJECTIVES: Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS. Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.

Detailed description

STUDY ACTIVITIES AND POPULATION GROUP: This is an open-label, non-randomized, single center phase 2 trial. A treatment cycle will consist of 4 weeks of therapy. Sorafenib will be administered at a set dose of 400 mg (2 x 200 mg tablets) twice daily, without food (at least 1 hour before or 2 hours after eating). Temozolomide will be administered at a set dose of 50 mg/m2 once daily without food (at least 1 hour before or 2 hours after eating). Thirty-two (32) patients will be enrolled in this single-stage study. DATA ANALYSIS AND RISK/SAFETY ISSUES: After 16 patients with recurrent GBM are treated, an interim analysis will be conducted. If 6 or more patients have experienced unacceptable toxicity, accrual of patients in this patient group will be terminated. Otherwise, patient accrual will continue. If 9 or more of the total 32 patients experience unacceptable toxicity, the treatment regimen will be considered to have an unacceptable toxicity profile. The type I and II error rates associated with this testing are 0.053 and 0.053, respectively.

Conditions

• Recurrent Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Sorafenib and Temozolomide	Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-02-01
• Completion: 2010-12-01
• First posted: 2008-01-18
• Last updated: 2013-06-24
• Results posted: 2013-06-24

Locations

1 site across 1 country: United States