drugset / Trial / 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)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2003-05-27
- Primary completion
- 2005-06-17
- Completion
- 2005-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 100 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | Oral |