search
Back to results

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

Primary Purpose

Recurrent Glioblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
enzastaurin
bevacizumab
Enzyme-inducing antiepileptic drugs (EIAED)
Non-enzyme inducing antiepileptic drugs (NEIAED)
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzastaurin + Bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival at 6 Months (PFS-6)
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).
Time to Progressive Disease (PD)
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)
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.

Secondary Outcome Measures

Overall Response Rate (ORR)
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
Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales
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.

Full Information

First Posted
December 7, 2007
Last Updated
September 23, 2020
Sponsor
Eli Lilly and Company
Collaborators
Genentech, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00586508
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzastaurin + Bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
enzastaurin
Other Intervention Name(s)
LY317615
Intervention Description
1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).
Intervention Type
Drug
Intervention Name(s)
Enzyme-inducing antiepileptic drugs (EIAED)
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Non-enzyme inducing antiepileptic drugs (NEIAED)
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Progression-Free Survival at 6 Months (PFS-6)
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).
Time Frame
Registration to 6 months
Title
Time to Progressive Disease (PD)
Description
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.
Time Frame
Registration to PD, death or date of last contact up to 66.56 months
Title
Number of Participants With Adverse Events (AEs) or Deaths (Safety)
Description
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.
Time Frame
Registration to study completion up to 67.56 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Registration to date of objective PD or death up to 66.56 months
Title
To Evaluate Tumor Markers and Genes
Time Frame
Baseline and every cycle (4-week cycles)
Title
Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales
Description
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.
Time Frame
Baseline, Cycles 1-12 (4-week cycles)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Bethesda
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26643807
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.
Results Reference
derived
PubMed Identifier
25098701
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.
Results Reference
derived

Learn more about this trial

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

We'll reach out to this number within 24 hrs