Malignant GliomaPhase 2NCT00190723
A Study of LY317615 in Patients With Brain Tumors
A Phase 2 study testing Enzastaurin in people with Malignant Glioma, run by Eli Lilly and Company at 1 site in United States.
Trial summary
1. The safety of LY317615 and any side effects that might be associated with the drug. 2. Whether LY317615, can help patients with brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Enzastaurin
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2006
- Phase
- Phase 2
- 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
- You must be at least 18 years old
- You must have been diagnosed with a recurrent brain tumor by MRI or CT scan
- You must be able to swallow the LY317615 tablets
Who cannot join
- You are a woman who is pregnant or breastfeeding
- In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease
Trial locations and contacts
1 site in 1 country.
United States1 site
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
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
- The safety of LY317615 and any side effects that might be associated with the drug.
- Whether LY317615, can help patients with brain tumors.
- Conditions
- Malignant Glioma
- Being tested
- Enzastaurin
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzastaurinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
Secondary outcomes (1)
To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190723
- Sponsor's protocol ID
- 5799
- Other IDs
- H6Q-MC-JCAJ
- Status last verified
- Jan 2007
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of LY317615 in Patients With Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00190723
- Acronym / sponsor ID
- 5799
- Conditions
- Malignant Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Dec 2006
- First posted
- 19 Sep 2005 (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.
- The safety of LY317615 and any side effects that might be associated with the drug.
- Whether LY317615, can help patients with brain tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You must be at least 18 years old
- You must have been diagnosed with a recurrent brain tumor by MRI or CT scan
- You must be able to swallow the LY317615 tablets
Key exclusion criteria (2 listed)
- You are a woman who is pregnant or breastfeeding
- In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease
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 |
|---|---|---|
| Enzastaurin | Drug | – |
Primary outcome
To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.
1 secondary outcome
To obtain preliminary information regarding the spectrum of toxicities of LY317615 administered to patients with recurrent high-grade gliomas
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 26 Jan 2007.
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzastaurin in people with Malignant Glioma, run by Eli Lilly and Company at 1 site in United States.
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 3 inclusion and 2 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To establish data regarding the anti-tumor activity of LY317615 in patients with recurrent high-grade gliomas.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2007.