Enzastaurin Versus Lomustine in Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00295815
First received: February 22, 2006
Last updated: June 12, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • To measure changes in patient's ability to care for themselves (this will be determined through a standard survey). [ Time Frame: over entire study ] [ Designated as safety issue: No ]
  • To measure changes from baseline and a neurologic exam. [ Time Frame: baseline, each cycle ] [ Designated as safety issue: Yes ]
  • To review all bad reactions reported by the patient and detected in blood tests. [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine through blood tests how long the medication is in the patient's body. [ Time Frame: cycle 1, cycle 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295815

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Locations
United States, Arizona
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Phoenix, Arizona, United States, 85013
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Tucson, Arizona, United States, 85724
United States, California
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Berkeley, California, United States, 94704
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San Francisco, California, United States, 94143
United States, Colorado
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Aurora, Colorado, United States, 80010
United States, Delaware
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Newark, Delaware, United States, 19718
United States, Florida
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Tampa, Florida, United States, 33612
United States, Georgia
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United States, Hawaii
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United States, Illinois
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Peoria, Illinois, United States, 61615
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kansas
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United States, Maryland
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Bethesda, Maryland, United States, 20892
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
United States, Michigan
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Detroit, Michigan, United States, 48202
United States, Minnesota
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Minneapolis, Minnesota, United States, 55455
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Rochester, Minnesota, United States, 55905
United States, Missouri
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St Louis, Missouri, United States, 63110
United States, Nebraska
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United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
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United States, New York
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United States, North Carolina
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United States, Ohio
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Columbus, Ohio, United States, 43210
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
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Memphis, Tennessee, United States, 38138
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Nashville, Tennessee, United States, 37203
United States, Texas
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Lubbock, Texas, United States, 79410
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San Antonio, Texas, United States, 78258
United States, Utah
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United States, Virginia
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Charlottesville, Virginia, United States, 22908
United States, Washington
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United States, Wisconsin
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Madison, Wisconsin, United States, 53792
Australia, New South Wales
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Liverpool, New South Wales, Australia, 2170
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
Australia, Victoria
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Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Austria
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Graz, Austria, 8036
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Innsbruck, Austria, 5020
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Linz, Austria, A-4020
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Wien, Austria, A-1100
Belgium
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Brussels, Belgium, 1200
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Leuven, Belgium, B-3000
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Liège, Belgium, 4000
Canada, Ontario
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London, Ontario, Canada, N6A 4L6
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Ottawa, Ontario, Canada, K1H 1C4
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Toronto, Ontario, Canada, M5G 2M9
France
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Lyon, France, 69395
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Marseille, France, 13385
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Nancy, France, 54035
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Paris, France, 75013
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Poitiers, France, 86000
Germany
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Bonn, Germany, D-53105
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Dresden, Germany, 01307
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Freiburg, Germany, 79106
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Heidelberg, Germany, 69120
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München, Germany, 81377
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Tübingen, Germany, 72076
India
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Mumbai, India, 400 012
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New Delhi, India, 110 029
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Vellore, India, 632 004
Italy
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Bologna, Italy, 40139
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Milano, Italy, 20133
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Napoli, Italy, 80131
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Roma, Italy, 00128
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Torino, Italy, 10126
Mexico
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Ciudad Obregon, Mexico, 85100
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Guadalajara, Mexico, 44280
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Mexico City, Mexico, 11640
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Monterrey, Mexico, 64060
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Tijuana, Mexico, 22329
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Tlalpan, Mexico, 14269
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Toluca, Mexico, 52140
Netherlands
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Amsterdam, Netherlands, 1105 AZ
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Den Haag, Netherlands, 2512 VA
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Maastricht, Netherlands, 6229 HX
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Rotterdam, Netherlands, 3075 EA
Poland
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Lublin, Poland, 20-950
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Warsaw, Poland, 02-781
Spain
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Badalona, Spain, 08915
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Hospitalet Llobregat, Spain, 08907
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Madrid, Spain, 28040
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Oviedo, Spain, 33006
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Valencia, Spain, 46014
United Kingdom
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Bristol, Avon, United Kingdom, BS2 8ED
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Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
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Edinburgh, Scotland, United Kingdom, EH4 2XU
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Glasgow, Scotland, United Kingdom, G11 6NT
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00295815     History of Changes
Other Study ID Numbers: 9817, H6Q-MC-JCBF
Study First Received: February 22, 2006
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014