A Study of LY317615 in Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190723
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Information provided by:
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Enzastaurin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
Study Start Date : October 2002
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.

Secondary Outcome Measures :
  1. To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190723

United States, Maryland
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, United States, 20892
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company Identifier: NCT00190723     History of Changes
Obsolete Identifiers: NCT00047892, NCT00052663
Other Study ID Numbers: 5799
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue