Trials / Completed
CompletedNCT00335075
Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)
A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 151 (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 and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Temozolomide | Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy. |
| DRUG | Semustine | Semustine orally once every 28 days at a dose of 150 mg/m2/day. |
Timeline
- Start date
- 2005-03-02
- Primary completion
- 2006-02-23
- Completion
- 2006-02-23
- First posted
- 2006-06-08
- Last updated
- 2017-05-15
Source: ClinicalTrials.gov record NCT00335075. Inclusion in this directory is not an endorsement.