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 is an investigational small molecule being studied for the treatment of glioblastoma multiforme, a type of brain cancer. It is taken orally once daily at a 500 milligram dose. The drug is currently in clinical development and has not been approved by regulatory authorities.
Enzastaurin 500 milligram Once Daily is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma multiforme.
Enzastaurin 500 milligram Once Daily is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of glioblastoma multiforme, and its safety and effectiveness are still being evaluated in clinical trials.
Enzastaurin 500 milligram Once Daily has one completed clinical trial, identified as NCT00509821. This Phase 2 study, titled "Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma," enrolled 60 participants in Germany. The trial was controlled but not randomized or double-blind.
Enzastaurin 500 milligram Once Daily is a specific dosing regimen of the drug enzastaurin. The name specifies the dose and frequency of administration, which is 500 milligrams taken once daily. This regimen is being studied in clinical trials for the treatment of glioblastoma multiforme.