home/imdoinit.org

Enzastaurin Versus Lomustine in Glioblastoma

Study Purpose

This protocol will test the activity of Enzastaurin vs.#46; Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00295815
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	Australia, Austria, Belgium, Canada, France, Germany, India, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

Experimental: A

Active Comparator: B

Interventions

Drug: - enzastaurin

1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD

Drug: - lomustine

100-130 mg/m2, oral once, every 6 weeks until PD

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Address

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.

Phoenix, Arizona, 85013

Tucson, Arizona

Status

Address

Tucson, Arizona, 85724

Berkeley, California

Status

Address

Berkeley, California, 94704

Los Angeles, California

Status

Address

Los Angeles, California, 90048

San Francisco, California

Status

Address

San Francisco, California, 94143

Aurora, Colorado

Status

Address

Aurora, Colorado, 80010

Newark, Delaware

Status

Address

Newark, Delaware, 19718

Tampa, Florida

Status

Address

Tampa, Florida, 33612

Atlanta, Georgia

Status

Address

Atlanta, Georgia, 30322

Honolulu, Hawaii

Status

Address

Honolulu, Hawaii, 96813

Chicago, Illinois

Status

Address

Chicago, Illinois, 60611

Peoria, Illinois

Status

Address

Peoria, Illinois, 61615

Iowa City, Iowa

Status

Address

Iowa City, Iowa, 52242

Kansas City, Kansas

Status

Address

Kansas City, Kansas, 66160

Baltimore, Maryland

Status

Address

Baltimore, Maryland, 21231

Bethesda, Maryland

Status

Address

Bethesda, Maryland, 20892

Boston, Massachusetts

Status

Address

Boston, Massachusetts, 02114

Detroit, Michigan

Status

Address

Detroit, Michigan, 48202

Minneapolis, Minnesota

Status

Address

Minneapolis, Minnesota, 55455

Rochester, Minnesota

Status

Address

Rochester, Minnesota, 55905

Columbia, Missouri

Status

Address

Columbia, Missouri, 65203

Saint Louis, Missouri

Status

Address

Saint Louis, Missouri, 63110

Omaha, Nebraska

Status

Address

Omaha, Nebraska, 68114

Las Vegas, Nevada

Status

Address

Las Vegas, Nevada, 89135

Lebanon, New Hampshire

Status

Address

Lebanon, New Hampshire, 03756

Albuquerque, New Mexico

Status

Address

Albuquerque, New Mexico, 87106

Santa Fe, New Mexico

Status

Address

Santa Fe, New Mexico, 87505

Buffalo, New York

Status

Address

Buffalo, New York, 14226

New York, New York

Status

Address

New York, New York, 10021

Winston-Salem, North Carolina

Status

Address

Winston-Salem, North Carolina, 27157

Columbus, Ohio

Status

Address

Columbus, Ohio, 43210

Pittsburgh, Pennsylvania

Status

Address

Pittsburgh, Pennsylvania, 15232

Memphis, Tennessee

Status

Address

Memphis, Tennessee, 38138

Nashville, Tennessee

Status

Address

Nashville, Tennessee, 37203

Dallas, Texas

Status

Address

Dallas, Texas, 75246

Houston, Texas

Status

Address

Houston, Texas, 77030

Lubbock, Texas

Status

Address

Lubbock, Texas, 79410

San Antonio, Texas

Status

Address

San Antonio, Texas, 78258

Salt Lake City, Utah

Status

Address

Salt Lake City, Utah, 84132

Charlottesville, Virginia

Status

Address

Charlottesville, Virginia, 22908

Seattle, Washington

Status

Address

Seattle, Washington, 98195

Madison, Wisconsin

Status

Address

Madison, Wisconsin, 53792

International Sites

Liverpool, New South Wales, Australia

Status

Address

Liverpool, New South Wales, 2170

St Leonards, New South Wales, Australia

Status

Address

St Leonards, New South Wales, 2065

Auchenflower, Queensland, Australia

Status

Address

Auchenflower, Queensland, 4066

Heidelberg, Victoria, Australia

Status

Address

Heidelberg, Victoria, 3084

Nedlands, Western Australia, Australia

Status

Address

Nedlands, Western Australia, 6009

Graz, Austria

Status

Address

Graz, , 8036

Innsbruck, Austria

Status

Address

Innsbruck, , 5020

Linz, Austria

Status

Address

Linz, , A-4020

Wien, Austria

Status

Address

Wien, , A-1100

Brussels, Belgium

Status

Address

Brussels, , 1200

Leuven, Belgium

Status

Address

Leuven, , B-3000

Liège, Belgium

Status

Address

Liège, , 4000

London, Ontario, Canada

Status

Address

London, Ontario, N6A 4L6

Ottawa, Ontario, Canada

Status

Address

Ottawa, Ontario, K1H 1C4

Toronto, Ontario, Canada

Status

Address

Toronto, Ontario, M5G 2M9

Lyon, France

Status

Address

Lyon, , 69395

Marseille, France

Status

Address

Marseille, , 13385

Nancy, France

Status

Address

Nancy, , 54035

Paris, France

Status

Address

Paris, , 75013

Poitiers, France

Status

Address

Poitiers, , 86000

Bonn, Germany

Status

Address

Bonn, , D-53105

Dresden, Germany

Status

Address

Dresden, , 01307

Freiburg, Germany

Status

Address

Freiburg, , 79106

Heidelberg, Germany

Status

Address

Heidelberg, , 69120

München, Germany

Status

Address

München, , 81377

Tübingen, Germany

Status

Address

Tübingen, , 72076

Mumbai, India

Status

Address

Mumbai, , 400 012

New Delhi, India

Status

Address

New Delhi, , 110 029

Vellore, India

Status

Address

Vellore, , 632 004

Bologna, Italy

Status

Address

Bologna, , 40139

Milano, Italy

Status

Address

Milano, , 20133

Napoli, Italy

Status

Address

Napoli, , 80131

Roma, Italy

Status

Address

Roma, , 00128

Torino, Italy

Status

Address

Torino, , 10126

Ciudad Obregon, Mexico

Status

Address

Ciudad Obregon, , 85100

Guadalajara, Mexico

Status

Address

Guadalajara, , 44280

Mexico City, Mexico

Status

Address

Mexico City, , 11640

Monterrey, Mexico

Status

Address

Monterrey, , 64060

Tijuana, Mexico

Status

Address

Tijuana, , 22329

Tlalpan, Mexico

Status

Address

Tlalpan, , 14269

Toluca, Mexico

Status

Address

Toluca, , 52140

Amsterdam, Netherlands

Status

Address

Amsterdam, , 1105 AZ

Den Haag, Netherlands

Status

Address

Den Haag, , 2512 VA

Maastricht, Netherlands

Status

Address

Maastricht, , 6229 HX

Rotterdam, Netherlands

Status

Address

Rotterdam, , 3075 EA

Lublin, Poland

Status

Address

Lublin, , 20-950

Warsaw, Poland

Status

Address

Warsaw, , 02-781

Badalona, Spain

Status

Address

Badalona, , 08915

Hospitalet Llobregat, Spain

Status

Address

Hospitalet Llobregat, , 08907

Madrid, Spain

Status

Address

Madrid, , 28040

Oviedo, Spain

Status

Address

Oviedo, , 33006

Valencia, Spain

Status

Address

Valencia, , 46014

Bristol, Avon, United Kingdom

Status

Address

Bristol, Avon, BS2 8ED

Cambridge, Cambridgeshire, United Kingdom

Status

Address

Cambridge, Cambridgeshire, CB2 2QQ

Edinburgh, Scotland, United Kingdom

Status

Address

Edinburgh, Scotland, EH4 2XU

Glasgow, Scotland, United Kingdom

Status

Address

Glasgow, Scotland, G11 6NT

Clinical Trial Finder

Enzastaurin Versus Lomustine in Glioblastoma

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Trial Details

Arms

Interventions

Contact a Trial Team

International Sites