Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT 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.
Study:
NCT00597493
Study Brief:
Protocol Section:
NCT00597493