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Brief Title: Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM
Official Title: Phase 2 Study of Sorafenib Plus Protracted Temozolomide in Recurrent Glioblastoma Multiforme
Study ID: NCT00597493
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Duke University Health System, Durham, North Carolina, United States
Name: David A Reardon, MD
Affiliation: Duke Health
Role: PRINCIPAL_INVESTIGATOR