Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00335075 | Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644) | PHASE3 | COMPLETED | 151 | — | — | Mar 2, 2005 | Feb 23, 2006 | May 15, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| Temodal group | EXPERIMENTAL | Subjects treated with temozolomide. |
| Semustine group | ACTIVE_COMPARATOR | Subjects treated with semustine. |
| Name | Type | Description |
|---|---|---|
| Temozolomide | DRUG | 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. |
| Semustine | DRUG | Semustine orally once every 28 days at a dose of 150 mg/m2/day. |
Inclusion Criteria: * Prior histologic confirmation of glioblastoma, anaplastic astrocytoma. * Evidence of tumor progression or recurrence. * Age \>=18 years. * Karnofsky performance status \>=60%. * Absolute neutrophil count \>=1,500/mm\^3, platelet count \>=100,000/mm\^3, hemoglobin \>=8g/dL. * S...