NCT00783393

SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)

SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.

Conditions

• Astrocytoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.

Timeline

• Start date: 2003-05-27
• Primary completion: 2005-06-17
• Completion: 2005-06-17
• First posted: 2008-10-31
• Last updated: 2017-05-15