Trials / Completed
CompletedNCT03776071
A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- Denovo Biopharma LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all eligibility criteria will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Enzastaurin Hydrochloride | mg |
| OTHER | Placebo | mg |
| DRUG | Temozolomide | mg/m\^2 |
| RADIATION | Radiotherapy | Gy |
Timeline
- Start date
- 2020-12-16
- Primary completion
- 2024-02-29
- Completion
- 2024-02-29
- First posted
- 2018-12-14
- Last updated
- 2024-04-22
Locations
65 sites across 3 countries: United States, Canada, China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03776071. Inclusion in this directory is not an endorsement.