Back to resultsA Study of LY317615 in Patients With Brain Tumors
Primary Purpose
Malignant Glioma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enzastaurin
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma
Eligibility Criteria
Inclusion Criteria: You must be at least 18 years old You must have been diagnosed with a recurrent brain tumor by MRI or CT scan You must be able to swallow the LY317615 tablets Exclusion Criteria: You are a woman who is pregnant or breastfeeding In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease
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
Outcomes
Primary Outcome Measures
To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
Secondary Outcome Measures
To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
Full Information
NCT ID
NCT00190723
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00190723
Brief Title
A Study of LY317615 in Patients With Brain Tumors
Official Title
A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The safety of LY317615 and any side effects that might be associated with the drug.
Whether LY317615, can help patients with brain tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Enzastaurin
Primary Outcome Measure Information:
Title
To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
Secondary Outcome Measure Information:
Title
To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You must be at least 18 years old
You must have been diagnosed with a recurrent brain tumor by MRI or CT scan
You must be able to swallow the LY317615 tablets
Exclusion Criteria:
You are a woman who is pregnant or breastfeeding
In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease
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
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of LY317615 in Patients With Brain Tumors
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