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Enzastaurin Versus Lomustine in Glioblastoma

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.
 
ClinicalTrials.gov Identifier: NCT00295815
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: enzastaurin Drug: lomustine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
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
Study Start Date : January 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lomustine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [ Time Frame: over entire study ]
  3. To measure changes from baseline and a neurologic exam. [ Time Frame: baseline, each cycle ]
  4. To review all bad reactions reported by the patient and detected in blood tests. [ Time Frame: each cycle ]
  5. 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 ]
  6. To determine through blood tests how long the medication is in the patient's body. [ Time Frame: cycle 1, cycle 4 ]
  7. 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 ]


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
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.

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


Locations
Show Show 98 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Publications of Results:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00295815    
Other Study ID Numbers: 9817
H6Q-MC-JCBF ( Other Identifier: Eli Lilly and Company )
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Additional relevant MeSH terms:
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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