Malignant Glioma Clinical Trial
Official title:
A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
Verified date | January 2007 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
1. The safety of LY317615 and any side effects that might be associated with the drug.
2. Whether LY317615, can help patients with brain tumors.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas. | |||
Secondary | To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas |
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