Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
397 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-01-31
Study Completion Date
2014-05-31
Brief Summary
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This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
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Detailed Description
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Conditions
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Glioblastoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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A
Group Type
EXPERIMENTAL
enzastaurin
Intervention Type
DRUG
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
B
Group Type
ACTIVE_COMPARATOR
lomustine
Intervention Type
DRUG
100-130 mg/m2, oral once, every 6 weeks until PD
Interventions
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enzastaurin
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
Intervention Type
DRUG
lomustine
100-130 mg/m2, oral once, every 6 weeks until PD
Intervention Type
DRUG
Other Intervention Names
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LY317615
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Berkeley, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Newark, Delaware, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Santa Fe, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Heidelberg, Victoria, Australia
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Nedlands, Western Australia, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Lyon, , France
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Marseille, , France
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Nancy, , France
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Paris, , France
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Poitiers, , France
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Bonn, , Germany
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Dresden, , Germany
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Freiburg im Breisgau, , Germany
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Heidelberg, , Germany
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München, , Germany
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Tübingen, , Germany
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Mumbai, , India
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New Delhi, , India
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Vellore, , India
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Bologna, , Italy
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Milan, , Italy
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Napoli, , Italy
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Roma, , Italy
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Torino, , Italy
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Ciudad Obregón, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Tijuana, , Mexico
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Tlalpan, , Mexico
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Toluca, , Mexico
Site Status
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Amsterdam, , Netherlands
Site Status
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Maastricht, , Netherlands
Site Status
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Rotterdam, , Netherlands
Site Status
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The Hague, , Netherlands
Site Status
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Lublin, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Badalona, , Spain
Site Status
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Hospitalet Llobregat, , Spain
Site Status
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Madrid, , Spain
Site Status
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Oviedo, , Spain
Site Status
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Valencia, , Spain
Site Status
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Bristol, Avon, United Kingdom
Site Status
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Cambridge, Cambridgeshire, United Kingdom
Site Status
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Edinburgh, Scotland, United Kingdom
Site Status
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.
Glasgow, Scotland, United Kingdom
Site Status
Countries
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United States
Australia
Austria
Belgium
Canada
France
Germany
India
Italy
Mexico
Netherlands
Poland
Spain
United Kingdom
References
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Wick W, Puduvalli VK, Chamberlain MC, van den Bent MJ, Carpentier AF, Cher LM, Mason W, Weller M, Hong S, Musib L, Liepa AM, Thornton DE, Fine HA. Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma. J Clin Oncol. 2010 Mar 1;28(7):1168-74. doi: 10.1200/JCO.2009.23.2595. Epub 2010 Feb 1.
Reference Type
RESULT
Other Identifiers
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H6Q-MC-JCBF
Identifier Type: OTHER
Identifier Source: secondary_id
9817
Identifier Type: -
Identifier Source: org_study_id
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