Phase 2
Completed N=81
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
Source: ClinicalTrials.gov NCT00586508 ↗Enrolled (actual)
81
Serious AEs
34.6%
Results posted
Sep 2020
Primary outcomePrimary: Progression-Free Survival at 6 Months (PFS-6) — 31; 15 percentage of participants
Summary
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival at 6 Months (PFS-6) |
31; 15 | — |
| PRIMARY Time to Progressive Disease (PD) |
2.76; 1.84 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) or Deaths (Safety) |
24; 4; 68; 13; 5; 1 | — |
| SECONDARY Overall Response Rate (ORR) |
5.9; 0 | — |
| SECONDARY To Evaluate Tumor Markers and Genes |
— | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales |
1.4; 2.5; 1.2; 2.0; 2.3; -0.5 | 0.3375 |
Eligibility Criteria
Inclusion Criteria
- Participant must be at least 18 years old
- Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
- Participant must be willing to practice adequate contraception
- Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
- Participant must agree to use the study drug only as instructed by your study doctor and staff.
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Participants who have significant heart, liver, kidney, or psychiatric disease
- Participants who have an active infection
- Participants who have any recent bleeding in the brain
- Participants who are taking any anti-coagulation or anti-platelet medication [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors]
Data sourced from ClinicalTrials.gov (NCT00586508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.