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Enzastaurin Versus Lomustine in Glioblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295815
First Posted: February 24, 2006
Last Update Posted: November 22, 2016
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 (Responsible Party):
Eli Lilly and Company
  Purpose
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

Condition Intervention Phase
Glioblastoma Drug: enzastaurin Drug: lomustine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening). [ Time Frame: baseline to measured progressive disease (PD) ]

Secondary Outcome Measures:
  • To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique). [ Time Frame: time of response to progressive disease ]
  • To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [ Time Frame: over entire study ]
  • To measure changes from baseline and a neurologic exam. [ Time Frame: baseline, each cycle ]
  • To review all bad reactions reported by the patient and detected in blood tests. [ Time Frame: each cycle ]
  • To review the effect of the cancer on the patient's ability to care for themselves and on their general health status. [ Time Frame: over entire study ]
  • To determine through blood tests how long the medication is in the patient's body. [ Time Frame: cycle 1, cycle 4 ]
  • To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients. [ Time Frame: baseline, cycle 2, end of study ]

Enrollment: 397
Study Start Date: January 2006
Study Completion Date: May 2014
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
Other Name: LY317615
Active Comparator: B Drug: lomustine
100-130 mg/m2, oral once, every 6 weeks until PD

  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:

  1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
  2. Your cancer has returned following therapy.
  3. Patient may have undergone prior surgery to remove cancer.
  4. Patient must be able to care for self.

Exclusion Criteria:

  1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
  2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
  3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
  4. Cannot be on blood thinning medication at study enrollment.
  5. Cannot be on other medicines to prevent cancer at study enrollment.
  6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.
  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): NCT00295815


  Show 98 Study Locations
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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Publications:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00295815     History of Changes
Other Study ID Numbers: 9817
H6Q-MC-JCBF ( Other Identifier: Eli Lilly and Company )
First Submitted: February 22, 2006
First Posted: February 24, 2006
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lomustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents