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NCT00190723 Clinical Trial

A Study of LY317615 in Patients With Brain Tumors

Malignant Glioma Clinical Trial

Official title:
A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190723
Other study ID # 5799
Secondary ID H6Q-MC-JCAJ
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated January 24, 2007
Start date October 2002
Est. completion date December 2006

Study information
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

Clinical Trial Summary

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.

Other known NCT identifiers
  • NCT00047892
  • NCT00052663

Recruitment information / eligibility
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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Enzastaurin

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
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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