Clinical trial NCT00586508: Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
Official title: A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Glioblastoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2008-01-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.


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 \[including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors\]

Primary outcomes:
measure: Progression-Free Survival at 6 Months (PFS-6)
timeFrame: Registration to 6 months
measure: Time to Progressive Disease (PD)
timeFrame: Registration to PD, death or date of last contact up to 66.56 months
measure: Number of Participants With Adverse Events (AEs) or Deaths (Safety)
timeFrame: Registration to study completion up to 67.56 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Registration to date of objective PD or death up to 66.56 months
measure: To Evaluate Tumor Markers and Genes
timeFrame: Baseline and every cycle (4-week cycles)
measure: Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales
timeFrame: Baseline, Cycles 1-12 (4-week cycles)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Odia 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.
citation: Odia 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.