Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of LY317615 in Patients With Brain Tumors
This study has been completed.
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00190723
  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 II

MedlinePlus related topics: Brain Cancer Cancer
Drug Information available for: Enzastaurin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers: 5799, H6Q-MC-JCAJ
Study First Received: September 12, 2005
Last Updated: January 24, 2007
ClinicalTrials.gov Identifier: NCT00190723  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
 Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services