- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190723
A Study of LY317615 in Patients With Brain Tumors
January 24, 2007 updated by: Eli Lilly and Company
A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
- The safety of LY317615 and any side effects that might be associated with the drug.
- Whether LY317615, can help patients with brain tumors.
Study Overview
Study Type
Interventional
Enrollment
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
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Secondary Outcome Measures
Outcome Measure |
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To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
January 26, 2007
Last Update Submitted That Met QC Criteria
January 24, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5799
- H6Q-MC-JCAJ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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