Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas
- Conditions
- Recurrent Glioblastoma
- Interventions
- Drug: Enzyme-inducing antiepileptic drugs (EIAED)Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)
- Registration Number
- NCT00586508
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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.
- 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]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enzastaurin + Bevacizumab Enzyme-inducing antiepileptic drugs (EIAED) - Enzastaurin + Bevacizumab Non-enzyme inducing antiepileptic drugs (NEIAED) - Enzastaurin + Bevacizumab bevacizumab - Enzastaurin + Bevacizumab enzastaurin -
- Primary Outcome Measures
Name Time Method Time to Progressive Disease (PD) Registration to PD, death or date of last contact up to 66.56 months Defined as the time from registration to PD, death or date of last contact. 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). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date.
Number of Participants With Adverse Events (AEs) or Deaths (Safety) Registration to study completion up to 67.56 months Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Progression-Free Survival at 6 Months (PFS-6) Registration to 6 months 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).
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Registration to date of objective PD or death up to 66.56 months Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)\*100.
To Evaluate Tumor Markers and Genes Baseline and every cycle (4-week cycles) Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales Baseline, Cycles 1-12 (4-week cycles) HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented.
Trial Locations
- Locations (1)
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.
🇺🇸Bethesda, Maryland, United States