Brief Summary

The purpose of the protocol was to induce a novel radiochemotherapy with enzastaurin as first-line treatment regimen in glioblastoma: Participants with active, unmethylated MGMT promoter were treated with enzastaurin before, concomitant, and after radiotherapy to determine safety and PFS at 6 months (PFS-6) in phase II.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach

1 country

10 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

8.4 years study duration

First Submitted

Initial submission to the registry

July 30, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed

3.1 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed

Last Updated

April 5, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

July 30, 2007

Results QC Date

May 30, 2018

Last Update Submit

January 9, 2019

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Progression Free Survival at 6 Months (PFS-6)
PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.Estimation using Kaplan-Meier technique.
Baseline to 6 months

Secondary Outcomes (3)

Percentage of Participants With Overall Survival at 1 and 2 Years After Surgery
Baseline to 1 and 2 year
Response Rate
Baseline to 30 months
Change in Neurologic Status as Measured by Mini Mental Status Questionnaire, Total Score
Baseline through Week 12 .

Study Arms (2)

Enzastaurin Once Daily (QD)

EXPERIMENTAL

Enzastaurin given orally (PO) once daily (QD). 1125 mg loading dose D(-)7 then 500 mg PO,QD with concomitant radiotherapy.

Drug: Enzastaurin 500 milligram (mg) Once Daily (QD)

Enzastaurin Twice Daily (BID)

EXPERIMENTAL

Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO, with concomitant radiotherapy.

Drug: Enzastaurin 250 mg Twice Daily (BID)

Interventions

Enzastaurin 500 milligram (mg) Once Daily (QD)DRUG

1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment.

Also known as: LY317615

Enzastaurin Once Daily (QD)

Enzastaurin 250 mg Twice Daily (BID)DRUG

1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment.

Also known as: LY317615

Enzastaurin Twice Daily (BID)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Present with newly diagnosed histologically proven supratentorial GBM.
Demonstration of an unmethylated MGMT-promotor
Participants must sign an informed consent document. Participants must be at least 18 years of age.
Estimated life expectancy of at least 12 weeks
Tumor tissue specimens (paraffin-embedded and/or frozen) from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of PKC-beta targets (for example, GSK3beta).
Disease evaluated by Gd-MRI (magnetic resonance imaging) within 72 hours postoperatively
Interval of greater than or equal to 2 and less than or equal to 4 weeks since surgery or biopsy
ECOG Performance Status of less than or equal to 2
Adequate organ function including the following:
adequate bone marrow reserve: white blood cell (WBC) count greater than or equal to 3.0 X 109/L, absolute neutrophil count (ANC) greater than or equal to 1.5 X 109/L, platelet count greater than or equal to 75.0 X 109/L, and hemoglobin greater than or equal to 10.0 g/dL (greater than or equal to 6.2 mmol/L).
Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (X ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.5 X ULN, or less than or equal to 5 X ULN with liver metastases
Renal: serum creatinine less than or equal to 1.5 X ULN
Blood clotting: prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits
Participants must discontinue use of enzyme-inducing antiepileptic drugs (EIAEDs) greater than or equal to 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs. Participants who must begin EIAED therapy while on study will be allowed to remain on study.
Clinically normal cardiac function without history of ischemic heart disease in the past 6 months and normal 12-lead electrocardiogram (ECG); no history of stroke

You may not qualify if:

Have a prior malignancy (other than glioblastoma, or adequately treated carcinoma in situ of the cervix, or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence
Unable to undergo Gd MRI
Prior chemotherapy within the last 5 years
Prior chemotherapy for a brain tumor
Prior radiotherapy of the head
Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin
History of coagulation disorder associated with bleeding, or recurrent thrombotic events
Are receiving concurrent administration of anticoagulant therapy
Placement of Gliadel® wafer at surgery
Have a serious concomitant systemic disorder (for example, active infection including HIV, or cardiac disease) - participants who are pregnant, anticipate becoming pregnant within 6 months after study participation, or are currently breast-feeding
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (10)

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.

Berlin, 13553, Germany

Location

Erlangen, 91054, Germany

Location

Frankfurt, D-60596, Germany

Location

Freiburg im Breisgau, 79106, Germany

Location

Hamburg, 22767, Germany

Location

Heidelberg, D-69120, Germany

Location

Leipzig, 04103, Germany

Location

Mannheim, 68167, Germany

Location

Regensburg, 93053, Germany

Location

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

enzastaurinBID protein, human

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

3 participants receiving 500 mg enzastaurin qd were not included in analysis for outcome measures per protocol.

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 30, 2007

First Posted

August 1, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2016

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-01

Locations

DE(10)

Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Enzastaurin Once Daily (QD)

Enzastaurin Twice Daily (BID)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Enzastaurin Once Daily (QD)

Enzastaurin Twice Daily (BID)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations