Clinical trial · Interventional
Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas
NCT00586508CI-TRIAL-00047302completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| enzastaurin | Drug | Enzastaurin | ALIAS |
| Enzyme-inducing antiepileptic drugs (EIAED) | Drug | — | UNRESOLVED |
| Non-enzyme inducing antiepileptic drugs (NEIAED) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Enzastaurin + Bevacizumab
- interventionNames
- Drug: enzastaurin
- Drug: bevacizumab
- Drug: Enzyme-inducing antiepileptic drugs (EIAED)
- Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)
Primary outcomes (3)
- measure
- Progression-Free Survival at 6 Months (PFS-6)
- timeFrame
- Registration to 6 months
- description
- Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
- measure
- Time to Progressive Disease (PD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors\]
References
Publications (2)
- DERIVEDOdia Y, Iwamoto FM, Moustakas A, Fraum TJ, Salgado CA, Li A, Kreisl TN, Sul J, Butman JA, Fine HA. A phase II trial of enzastaurin (LY317615) in combination with bevacizumab in adults with recurrent malignant gliomas. J Neurooncol. 2016 Mar;127(1):127-35. doi: 10.1007/s11060-015-2020-x. Epub 2015 Dec 7. PMID 26643807
- DERIVEDOdia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7. PMID 25098701