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Recurrent GlioblastomaPhase 2NCT00586508

Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas

A Phase 2 study testing enzastaurin, bevacizumab and Enzyme-inducing antiepileptic drugs (EIAED) in people with Recurrent Glioblastoma, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
enzastaurin, bevacizumab and Enzyme-inducing antiepileptic drugs (EIAED)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
Nov 2007to Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participant must be at least 18 years old
  • Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
  • Participant must be willing to practice adequate contraception
  • Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
  • Participant must agree to use the study drug only as instructed by your study doctor and staff.

Who cannot join

  • Women who are pregnant or breastfeeding
  • Participants who have significant heart, liver, kidney, or psychiatric disease
  • Participants who have an active infection
  • Participants who have any recent bleeding in the brain
  • Participants who are taking any anti-coagulation or anti-platelet medication [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors]

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

Other trials in United States

About this study

Official title: A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas

The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.

Being tested
enzastaurin, bevacizumab, Enzyme-inducing antiepileptic drugs (EIAED), Non-enzyme inducing antiepileptic drugs (NEIAED)
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 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).

  • bevacizumabDrug

    10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).

  • Enzyme-inducing antiepileptic drugs (EIAED)Drug

    Administered orally

  • Non-enzyme inducing antiepileptic drugs (NEIAED)Drug

    Administered orally

Study groups in NCT00586508
Study groupRoleWhat they receive
Enzastaurin + BevacizumabExperimentalNot described
Receives: Drug: enzastaurin; Drug: bevacizumab; Drug: Enzyme-inducing antiepileptic drugs (EIAED); Drug: Non-enzyme inducing antiepileptic drugs (NEIAED)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival at 6 Months (PFS-6)

    Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

    Measured: Registration to 6 months

  2. Time to Progressive Disease (PD)

    Defined as the time from registration to PD, death or date of last contact. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date.

    Measured: Registration to PD, death or date of last contact up to 66.56 months

  3. Number of Participants With Adverse Events (AEs) or Deaths (Safety)

    Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

    Measured: Registration to study completion up to 67.56 months

Secondary outcomes (3)

  1. Overall Response Rate (ORR)

    Overall response is confirmed complete response (CR) + partial response (PR). CR is complete disappearance of all measurable and evaluable disease, no new lesions, and no evidence of non-evaluable disease. PR is ≥50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions (or the 2 largest lesions), no progression of evaluable disease and no new lesions. ORR is calculated as (total number of participants with CR or PR from the start of registration until disease progression) / (the total number of participants treated)*100.

    Measured: Registration to date of objective PD or death up to 66.56 months

  2. To Evaluate Tumor Markers and Genes

    Measured: Baseline and every cycle (4-week cycles)

  3. Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales

    HRQoL was assessed with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) version 4. The instrument consists of 50 items with a 5-point rating scale for each item, where 0 = "not at all" and 4 = "very much." Physical well-being, social/family well-being and functional well-being subscales consist of 7 items each with scores ranging from 0-28. The emotional well-being subscale consists of 6 items with a score ranging from 0-24. The brain cancer-specific subscale consists of 23 items with a score ranging from 0-92. Higher scores in each subscale represent better QoL. Changes from baseline in the 4 core subscales are presented.

    Measured: Baseline, Cycles 1-12 (4-week cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00586508
Sponsor's protocol ID
11394
Other IDs
H6Q-MC-S033
Status last verified
Sep 2020
First submitted
7 Dec 2007
Last updated
24 Sep 2020
Data monitoring committee
No

Publications

  • Odia Y, Iwamoto FM, Moustakas A, Fraum TJ, Salgado CA, Li A, Kreisl TN, Sul J, Butman JA, Fine HA. A phase II trial of enzastaurin (LY317615) in combination with bevacizumab in adults with recurrent malignant gliomas. J Neurooncol. 2016 Mar;127(1):127-35. doi: 10.1007/s11060-015-2020-x. Epub 2015 Dec 7.

    PubMed 26643807

  • Odia Y, Shih JH, Kreisl TN, Fine HA. Bevacizumab-related toxicities in the National Cancer Institute malignant glioma trial cohort. J Neurooncol. 2014 Nov;120(2):431-40. doi: 10.1007/s11060-014-1571-6. Epub 2014 Aug 7.

    PubMed 25098701

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enzastaurin, bevacizumab and Enzyme-inducing antiepileptic drugs (EIAED) in people with Recurrent Glioblastoma, 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 5 inclusion and 5 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 24 Sep 2020. 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?

Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival at 6 Months (PFS-6) (time frame: Registration to 6 months). The study lists 3 primary outcomes in all. 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 NCT00586508, which also lists 2 linked publications.

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 24 Sep 2020.

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