Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enzastaurin 500 milligram Once Daily · 1 trial · 1 indication
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...
Enzastaurin 500 milligram Once Daily was studied in glioblastoma multiforme, a type of brain cancer. The dosing regimen refers to a 500 mg dose taken once daily. It was evaluated in participants with newly diagnosed glioblastoma as part of a Phase 2 clinical trial.
Enzastaurin 500 milligram Once Daily targets PRKCB, also known as protein kinase C beta. It is a small molecule inhibitor of this target. By inhibiting PRKCB, the drug aims to interfere with signaling pathways involved in tumor growth and survival.
Enzastaurin 500 milligram Once Daily is being developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly conducted the clinical research for this asset.
Enzastaurin 500 milligram Once Daily is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial for glioblastoma multiforme has been completed.
Enzastaurin 500 milligram Once Daily was studied in one clinical trial: NCT00509821, titled "Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma." This Phase 2 trial enrolled 60 participants in Germany and is now completed.