NCT00295815

Brief Summary

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3

Geographic Reach
13 countries

93 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

February 22, 2006

Last Update Submit

September 10, 2019

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (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).

    baseline to measured progressive disease (PD)

Secondary Outcomes (7)

  • To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).

    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).

    over entire study

  • To measure changes from baseline and a neurologic exam.

    baseline, each cycle

  • To review all bad reactions reported by the patient and detected in blood tests.

    each cycle

  • To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.

    over entire study

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: enzastaurin

B

ACTIVE COMPARATOR
Drug: lomustine

Interventions

enzastaurinDRUG

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

Also known as: LY317615
A
lomustineDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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.
  • Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
  • Cannot be on blood thinning medication at study enrollment.
  • Cannot be on other medicines to prevent cancer at study enrollment.
  • Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (98)

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85724, United States

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Berkeley, California, 94704, United States

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Los Angeles, California, 90048, United States

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San Francisco, California, 94143, United States

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Aurora, Colorado, 80010, United States

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Newark, Delaware, 19718, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30322, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60611, United States

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Peoria, Illinois, 61615, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21231, United States

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Bethesda, Maryland, 20892, United States

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Boston, Massachusetts, 02114, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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Rochester, Minnesota, 55905, United States

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Columbia, Missouri, 65203, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89135, United States

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Lebanon, New Hampshire, 03756, United States

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Albuquerque, New Mexico, 87106, United States

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Santa Fe, New Mexico, 87505, United States

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Buffalo, New York, 14226, United States

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New York, New York, 10021, United States

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Winston-Salem, North Carolina, 27157, United States

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Columbus, Ohio, 43210, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Memphis, Tennessee, 38138, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78258, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Seattle, Washington, 98195, United States

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Madison, Wisconsin, 53792, United States

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Liverpool, New South Wales, 2170, Australia

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St Leonards, New South Wales, 2065, Australia

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Auchenflower, Queensland, 4066, Australia

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Heidelberg, Victoria, 3084, Australia

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Nedlands, Western Australia, 6009, Australia

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Graz, 8036, Austria

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Innsbruck, 5020, Austria

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Linz, A-4020, Austria

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Vienna, A-1100, Austria

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Brussels, 1200, Belgium

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Leuven, B-3000, Belgium

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Liège, 4000, Belgium

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London, Ontario, N6A 4L6, Canada

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Ottawa, Ontario, K1H 1C4, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Lyon, 69395, France

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Marseille, 13385, France

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Nancy, 54035, France

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Paris, 75013, France

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Poitiers, 86000, France

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Bonn, D-53105, Germany

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Dresden, 01307, Germany

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Freiburg im Breisgau, 79106, Germany

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Heidelberg, 69120, Germany

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München, 81377, Germany

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Tübingen, 72076, Germany

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Mumbai, 400 012, India

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New Delhi, 110 029, India

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Vellore, 632 004, India

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Bologna, 40139, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Roma, 00128, Italy

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Torino, 10126, Italy

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Ciudad Obregón, 85100, Mexico

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Guadalajara, 44280, Mexico

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Mexico City, 11640, Mexico

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Monterrey, 64060, Mexico

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Tijuana, 22329, Mexico

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Tlalpan, 14269, Mexico

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Toluca, 52140, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3075 EA, Netherlands

Location

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The Hague, 2512 VA, Netherlands

Location

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Lublin, 20-950, Poland

Location

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Warsaw, 02-781, Poland

Location

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Badalona, 08915, Spain

Location

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Hospitalet Llobregat, 08907, Spain

Location

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Madrid, 28040, Spain

Location

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Oviedo, 33006, Spain

Location

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Valencia, 46014, Spain

Location

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Bristol, Avon, BS2 8ED, United Kingdom

Location

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Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

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Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

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Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20124186RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

enzastaurinLomustine

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

May 1, 2014

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

BE(3)US(42)GB(4)IN(3)FR(5)AU(4)IT(5)DE(6)CA(3)PL(2)NL(4)ES(5)ME(7)