GlioblastomaPhase 3NCT00295815
Enzastaurin Versus Lomustine in Glioblastoma
A Phase 3 study testing enzastaurin and lomustine in people with Glioblastoma, run by Eli Lilly and Company at 98 sites in 14 countries.
Trial summary
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- enzastaurin and lomustine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 98 sitesin 14 countries
- Study dates
- Jan 2006to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
98 sites in 14 countries.
98 sites in 14 countries
United States42 sites
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Albuquerque, New Mexico, 87106
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Atlanta, Georgia, 30322
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Aurora, Colorado, 80010
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Baltimore, Maryland, 21231
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Berkeley, California, 94704
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Bethesda, Maryland, 20892
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Boston, Massachusetts, 02114
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Buffalo, New York, 14226
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60611
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Columbia, Missouri, 65203
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Columbus, Ohio, 43210
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Dallas, Texas, 75246
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Detroit, Michigan, 48202
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Honolulu, Hawaii, 96813
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Houston, Texas, 77030
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Iowa City, Iowa, 52242
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Kansas City, Kansas, 66160
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Las Vegas, Nevada, 89135
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Lebanon, New Hampshire, 03756
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Los Angeles, California, 90048
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Lubbock, Texas, 79410
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Madison, Wisconsin, 53792
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Memphis, Tennessee, 38138
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Minneapolis, Minnesota, 55455
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Nashville, Tennessee, 37203
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New York, New York, 10021
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Newark, Delaware, 19718
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Omaha, Nebraska, 68114
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Peoria, Illinois, 61615
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Phoenix, Arizona, 85013
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Pittsburgh, Pennsylvania, 15232
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Rochester, Minnesota, 55905
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Salt Lake City, Utah, 84132
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San Antonio, Texas, 78258
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San Francisco, California, 94143
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Santa Fe, New Mexico, 87505
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Seattle, Washington, 98195
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St Louis, Missouri, 63110
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Tampa, Florida, 33612
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Tucson, Arizona, 85724
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Winston-Salem, North Carolina, 27157
Mexico7 sites
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Ciudad Obregón, 85100
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Guadalajara, 44280
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Mexico City, 11640
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Monterrey, 64060
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Tijuana, 22329
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Tlalpan, 14269
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Toluca, 52140
Germany6 sites
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Bonn, D-53105
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Dresden, 01307
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Freiburg im Breisgau, 79106
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Heidelberg, 69120
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München, 81377
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Tübingen, 72076
Australia5 sites
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Auchenflower, Queensland, 4066
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Heidelberg, Victoria, 3084
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Liverpool, New South Wales, 2170
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Nedlands, Western Australia, 6009
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St Leonards, New South Wales, 2065
France5 sites
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Lyon, 69395
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Marseille, 13385
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Nancy, 54035
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Paris, 75013
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Poitiers, 86000
Italy5 sites
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Bologna, 40139
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Milan, 20133
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Naples, 80131
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Roma, 00128
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Torino, 10126
Spain5 sites
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Badalona, 08915
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Hospitalet Llobregat, 08907
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Madrid, 28040
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Oviedo, 33006
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Valencia, 46014
Austria4 sites
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Graz, 8036
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Innsbruck, 5020
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Linz, A-4020
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Vienna, A-1100
Netherlands4 sites
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Amsterdam, 1105 AZ
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Maastricht, 6229 HX
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Rotterdam, 3075 EA
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The Hague, 2512 VA
United Kingdom4 sites
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Bristol, Avon, BS2 8ED
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Cambridge, Cambridgeshire, CB2 2QQ
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Edinburgh, Scotland, EH4 2XU
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Glasgow, Scotland, G11 6NT
Belgium3 sites
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Brussels, 1200
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Leuven, B-3000
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Liège, 4000
Canada3 sites
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London, Ontario, N6A 4L6
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Ottawa, Ontario, K1H 1C4
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Toronto, Ontario, M5G 2M9
India3 sites
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Mumbai, 400 012
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New Delhi, 110 029
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Vellore, 632 004
Poland2 sites
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Lublin, 20-950
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.
Warsaw, 02-781
About this study
Official title: Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
- Conditions
- Glioblastoma
- Being tested
- enzastaurin, lomustine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzastaurinDrug
Also called LY317615
1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD
lomustineDrug
100-130 mg/m2, oral once, every 6 weeks until PD
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: enzastaurin |
| B | Active comparator | Not described Receives: Drug: lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: over entire study
To measure changes from baseline and a neurologic exam.
Measured: baseline, each cycle
To review all bad reactions reported by the patient and detected in blood tests.
Measured: each cycle
To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.
Measured: over entire study
To determine through blood tests how long the medication is in the patient's body.
Measured: cycle 1, cycle 4
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.
Measured: baseline, cycle 2, end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2007
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295815
- Sponsor's protocol ID
- 9817
- Other IDs
- H6Q-MC-JCBF
- Status last verified
- Sep 2019
- First submitted
- 22 Feb 2006
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 20124186
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
- ClinicalTrials.gov ID
- NCT00295815
- Acronym / sponsor ID
- 9817
- Conditions
- Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: enzastaurin |
| B | Active comparator | Drug: lomustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enzastaurinAlso: LY3176151125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD | Drug | A |
| lomustine100-130 mg/m2, oral once, every 6 weeks until PD | Drug | B |
Primary outcome
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)
7 secondary outcomes
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
To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).
Time frame: over entire study
To measure changes from baseline and a neurologic exam.
Time frame: baseline, each cycle
To review all bad reactions reported by the patient and detected in blood tests.
Time frame: each cycle
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
To determine through blood tests how long the medication is in the patient's body.
Time frame: cycle 1, cycle 4
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Results publication: PubMed 20124186Wick 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
98 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing enzastaurin and lomustine in people with Glioblastoma, run by Eli Lilly and Company at 98 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Mexico, Germany, Australia, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.