GlioblastomaPhase 1/2NCT00402116

Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients

A Phase 1/2 study testing enzastaurin, temozolomide and radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, 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

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study. The first phase of this study is done to evaluate the safety of enzastaurin in patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
What is being tested?: enzastaurin, temozolomide and radiation therapy
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Dec 2009
Phase: Phase 1/2
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

Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
An MRI or CT scan must be obtained within 14 days prior to treatment.
Patients must not have received prior drug therapy for brain tumors.
Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.

Who cannot join

Patients will be excluded if unable to swallow tablets.
Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.).
Patients will be excluded if have active infection.
Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.

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
San Francisco, California

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About this study

Official title: Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.

The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.

In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.

Conditions: Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
Being tested: enzastaurin, temozolomide, radiation therapy
Medical subject headings: Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

enzastaurinDrug
Also called LY317615
Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles
Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles
temozolomideDrug
75 milligrams per meter squared (mg/m^2), oral, daily, 6 weeks then 200 mg/m^2, oral, daily, twelve 28 day cycles
radiation therapyRadiation
1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks

Study groups in NCT00402116
Study group	Role	What they receive
A	Experimental	The Phase 1 consisted of the dose escalation of enzastaurin in 2 cohorts of up to 6 patients to assess maximum tolerated dose (MTD). Cohort 1 = radiotherapy/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy. The 6 initial cohort patients were clinically evaluated for dose-limiting toxicities (DLT). If no more than 1 of 6 patients experienced a DLT or tumor progression, patients continued 1 complete adjuvant enzastaurin/temozolomide 28-day cycle. If there was no significant toxicity after the first adjuvant cycle, participants received subsequent adjuvant enzastaurin/temozolomide cycles. If no more than 1 of the 6 initial cohort participants treated at 250 mg of enzastaurin experienced a DLT during radiotherapy and the first adjuvant cycle, up to 6 more participants could be entered at 500 mg of enzastaurin. The Phase 2, using the MTD determined in the Phase 1 (250 mg), evaluated the combination's safety and measured OS. Receives: Drug: enzastaurin; Drug: temozolomide; Radiation: radiation therapy

What is being measured

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

Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin
Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg).
Measured: Until MTD can be determined (up to 12 cycles, 28 days per cycle)
Phase 1 and Phase 2 - Overall Survival (OS)
OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact.
Measured: Baseline to death from any cause (Up to 48 weeks)

Secondary outcomes (10)

Phase 1 - Number of Participants With Adverse Events (AEs)
Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Measured: Every cycle (up to 12 cycles, 28 days per cycle)
Phase 1 and 2: Association Between Biomarkers and Clinical Outcome
Phosphorylated-S6 (pS6) ribosomal protein is a biomarker that's being investigated as a potential marker for clinical outcome using 2211 or 2215 antibody to pS6. Reported here are the hazard ratios and 95% confidence intervals (CIs) for participants for whom an pS6 immunohistochemistry (IHC) score was available. The IHC assays were scored using a 0 to +3 scoring system (no positive staining was scored 0; at least 25% immunoreactivity of cells was scored +1; 26% to 75% was scored +2; and 76% or greater was scored +3). Hazard ratio (HR) > 1 indicates worse outcome for that IHC score.
Measured: Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle)
Phase 1 - Response Rate With Macdonald Criteria
Response categories: complete response (CR): disappearance of all enhancing tumor on consecutive magnetic resonance imaging (MRI) scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response (PR): 50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): >25% increase in size of enhancing tumor or any new tumor on MRI scans, or neurologically worse, and steroids stable or increased. Stable disease (SD): all other situations.
Measured: Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle)
Phase 2 - Number of Participants With Adverse Events (AEs)
Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Measured: Every cycle (28 days per cycle)
Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline
Number of patients having MRI/MRS for clinical evaluation with baseline assessment.
Measured: Each radiologic assessment (up to 12 cycles, 28 days per cycle)
Phase 1 and 2 - Progression-Free Survival (PFS)
PFS was defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Measured: Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle)
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Total FACT-Br score includes physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns related to brain tumors. The score ranges 0 to 200, with a higher score representing better quality of life.
Measured: Every cycle (up to 12 cycles, 28 days per cycle)
M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
General and brain tumor-specific symptoms each assessed on a scale of 0 to 10, with a higher score representing higher symptom burden. The 4 symptom scales reported as changing over the course of the study are listed here.
Measured: Every cycle (up to 12 cycles, 28 days per cycle)
Phase 1- Pharmacokinetics (PK): Maximum Observed Drug Concentration During 1 Dosing Interval at Steady State (Cmax,ss) for Enzastaurin, LY326020, and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide
Cmax,ss was calculated using concentration versus time data of enzastaurin, LY326020, and Total Analyte (enzastaurin + LY326020) when 250 mg or 500 mg enzastaurin was administered alone or with 75 mg/m^2 temozolomide. Data are reported as Geometric Mean and Geometric Coefficient of Variation (%).
Measured: Cycle 1 Day 22, Cycle 2 Day 5, 28 days per Cycle
Phase 1 and 2- Pharmacokinetics: Area Under the Concentration-Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Enzastaurin, LY326020 and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide
AUCτ,ss was calculated using concentration versus time data of enzastaurin, LY326020, and total analyte (enzastaurin + LY326020). Data are reported as Geometric Mean and Geometric Coefficient of Variation (%).
Measured: Phase 1, Cycle 1 Day 22, Cycle 2 Day 5 of a 28 day Cycle; Phase 2, Cycle 1 Day 22 of a 28 day Cycle

Timeline

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

Sep 2006Dec 2009

First posted22 Nov 2006 (estimated)
Study startSep 2006
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402116
Sponsor's protocol ID: 9815
Other IDs: H6Q-MC-S008
Status last verified: Jul 2020
First submitted: 17 Nov 2006
Last updated: 6 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
ClinicalTrials.gov ID: NCT00402116
Acronym / sponsor ID: 9815
Conditions: Glioblastoma, Glioblastoma Multiforme, Gliosarcoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: University of California, San Francisco
Study start: Sep 2006
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 6 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
A	Experimental	Drug: enzastaurin, Drug: temozolomide, Radiation: radiation therapyThe Phase 1 consisted of the dose escalation of enzastaurin in 2 cohorts of up to 6 patients to assess maximum tolerated dose (MTD). Cohort 1 = radiotherapy/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy. The 6 initial cohort patients were clinically evaluated for dose-limiting toxicities (DLT). If no more than 1 of 6 patients experienced a DLT or tumor progression, patients continued 1 complete adjuvant enzastaurin/temozolomide 28-day cycle. If there was no significant toxicity after the first adjuvant cycle, participants received subsequent adjuvant enzastaurin/temozolomide cycles. If no more than 1 of the 6 initial cohort participants treated at 250 mg of enzastaurin experienced a DLT during radiotherapy and the first adjuvant cycle, up to 6 more participants could be entered at 500 mg of enzastaurin. The Phase 2, using the MTD determined in the Phase 1 (250 mg), evaluated the combination's safety and measured OS.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
An MRI or CT scan must be obtained within 14 days prior to treatment.
Patients must not have received prior drug therapy for brain tumors.
Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.

Key exclusion criteria (5 listed)

Patients will be excluded if unable to swallow tablets.
Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.).
Patients will be excluded if have active infection.
Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.

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: LY317615Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles Phase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles	Drug	A
temozolomide75 milligrams per meter squared (mg/m^2), oral, daily, 6 weeks then 200 mg/m^2, oral, daily, twelve 28 day cycles	Drug	A
radiation therapy1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks	Radiation	A

Primary outcome

Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin
Time frame: Until MTD can be determined (up to 12 cycles, 28 days per cycle)
Phase 1- dose escalation of enzastaurin in 2 cohorts up to 6 participants each in order to assess MTD. After radiation/enzastaurin 250 mg per day/temozolomide 75 mg/m^2 therapy, if no more than 1 of 6 patients experienced a dose-limiting toxicity (DLT) or tumor progression, participants completed one 28-day cycle. If no significant toxicity after the first cycle, participants received subsequent cycles. If no more than 1 of the 6 patients treated at 250 mg of enzastaurin experienced a DLT, up to 6 more patients could be entered at escalated dose cohort of enzastaurin (500 mg).
Phase 1 and Phase 2 - Overall Survival (OS)
Time frame: Baseline to death from any cause (Up to 48 weeks)
OS is the time from surgical diagnosis to the date of death from any cause. For participants who were alive, OS was censored at the last contact.

10 secondary outcomes

Phase 1 - Number of Participants With Adverse Events (AEs)
Time frame: Every cycle (up to 12 cycles, 28 days per cycle)
Phase 1 and 2: Association Between Biomarkers and Clinical Outcome
Time frame: Baseline, Cycle 2, end of study (up to 12 cycles, 28 days per cycle)
Phase 1 - Response Rate With Macdonald Criteria
Time frame: Baseline, following radiation, every other cycle (up to 12 cycles, 28 days per cycle)
Phase 2 - Number of Participants With Adverse Events (AEs)
Time frame: Every cycle (28 days per cycle)
Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline
Time frame: Each radiologic assessment (up to 12 cycles, 28 days per cycle)
Phase 1 and 2 - Progression-Free Survival (PFS)
Time frame: Baseline to measured progressive disease (up to 12 cycles, 28 days per cycle)
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Time frame: Every cycle (up to 12 cycles, 28 days per cycle)
M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Time frame: Every cycle (up to 12 cycles, 28 days per cycle)
Phase 1- Pharmacokinetics (PK): Maximum Observed Drug Concentration During 1 Dosing Interval at Steady State (Cmax,ss) for Enzastaurin, LY326020, and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide
Time frame: Cycle 1 Day 22, Cycle 2 Day 5, 28 days per Cycle
Phase 1 and 2- Pharmacokinetics: Area Under the Concentration-Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Enzastaurin, LY326020 and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide
Time frame: Phase 1, Cycle 1 Day 22, Cycle 2 Day 5 of a 28 day Cycle; Phase 2, Cycle 1 Day 22 of a 28 day Cycle

Results and safety

Results posted to the registry on 6 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1- Cohort 1 (250 mg Enzastaurin)	6	3
Phase 1 Cohort 2 (500 mg Enzastaurin)	6	0
Phase 2	60	5

Primary outcome: Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin

Time frame: Until MTD can be determined (up to 12 cycles, 28 days per cycle). Number. Unit: milligrams (mg)

Measure	Phase 1 Participants n = 12
Value	250

Population analysed: All Phase I participants who received at least one dose of study drug.

Primary outcome: Phase 1 and Phase 2 - Overall Survival (OS)

Time frame: Baseline to death from any cause (Up to 48 weeks). Median (95% Confidence Interval). Unit: months

Measure	250 mg Enzastaurin Phases 1 and 2 Combined n = 66
Value	18.3 (15.2 to 19.3)

Population analysed: Phase 2 participants combined with Phase 1 cohort 1 participants who also received 250 mg enzastaurin.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1- Cohort 1 (250 mg Enzastaurin)	0 of 6 (0%)	6 of 6 (100%)	Not reported
Phase 1 Cohort 2 (500 mg Enzastaurin)	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Phase 2 - 250 mg Enzastaurin	22 of 60 (36.7%)	60 of 60 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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 1/2 study testing enzastaurin, temozolomide and radiation therapy in people with Glioblastoma and Glioblastoma Multiforme, 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 6 Aug 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 6 Aug 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?

Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin (time frame: Until MTD can be determined (up to 12 cycles, 28 days per cycle)). The study lists 2 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 NCT00402116.

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 6 Aug 2020.