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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00295815 | Enzastaurin Versus Lomustine in Glioblastoma | PHASE3 | COMPLETED | 397 | — | — | Jan 1, 2006 | May 1, 2014 | Sep 12, 2019 | 98 | United States, Australia +12 |
| NCT00402116 | Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients | PHASE1 | COMPLETED | 72 | — | — | Sep 1, 2006 | Dec 1, 2009 | Aug 6, 2020 | 1 | United States |
Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m\^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg).
OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| enzastaurin | DRUG | 1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD |
| lomustine | DRUG | 100-130 mg/m2, oral once, every 6 weeks until PD |
| temozolomide | DRUG | 75 milligrams per meter squared (mg/m\^2), oral, daily, 6 weeks then 200 mg/m\^2, oral, daily, twelve 28 day cycles |
| radiation therapy | RADIATION | 1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks |
Inclusion Criteria: 1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme). 2. Your cancer has returned following therapy. 3. Patient may have undergone prior surgery to remove cancer. 4. Patient must be able to care for self. Exclusion C...