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A Study of LY317615 in Patients With Brain Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190723
First Posted: September 19, 2005
Last Update Posted: January 26, 2007
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.
Information provided by:
Eli Lilly and Company
  Purpose
  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 Intervention Phase
Malignant Glioma Drug: Enzastaurin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment: 120
Study Start Date: October 2002
Estimated Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00190723


Locations
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
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00190723     History of Changes
Obsolete Identifiers: NCT00047892, NCT00052663
Other Study ID Numbers: 5799
H6Q-MC-JCAJ
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: January 26, 2007
Last Verified: January 2007

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