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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00509821 | Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma | PHASE2 | COMPLETED | 60 | — | — | Oct 1, 2007 | Mar 1, 2016 | Apr 5, 2019 | 10 | Germany |
PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.Estimation using Kaplan-Meier technique.
| Arm | Type | Description |
|---|---|---|
| Enzastaurin Once Daily (QD) | EXPERIMENTAL | Enzastaurin given orally (PO) once daily (QD). 1125 mg loading dose D(-)7 then 500 mg PO,QD with concomitant radiotherapy. |
| Enzastaurin Twice Daily (BID) | EXPERIMENTAL | Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO, with concomitant radiotherapy. |
| Name | Type | Description |
|---|---|---|
| Enzastaurin 500 milligram (mg) Once Daily (QD) | DRUG | 1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment. |
| Enzastaurin 250 mg Twice Daily (BID) | DRUG | 1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment. |
Inclusion Criteria: * Present with newly diagnosed histologically proven supratentorial GBM. * Demonstration of an unmethylated MGMT-promotor * Participants must sign an informed consent document. Participants must be at least 18 years of age. * Estimated life expectancy of at least 12 weeks * Tumo...