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Enzastaurin + Temozolomide for Glioblastoma
Phase 3
Waitlist Available
Research Sponsored by Denovo Biopharma LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years with life expectancy > 12 weeks
Availability of tumor tissue representative of glioblastoma from surgery, and MGMT promoter methylation status is determined prior to study randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test a new treatment for brain cancer. It will compare the new treatment to a placebo, and 300 people will be enrolled.
Who is the study for?
Adults over 18 with newly diagnosed glioblastoma (excluding IDH mutant) can join this trial if they've had surgery but no prior treatments for their cancer. They must have a life expectancy of more than 12 weeks, good performance status, and proper organ function. Women of childbearing potential need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The study is testing Enzastaurin plus Temozolomide against placebo during and after radiation therapy in patients with glioblastoma. It's a randomized, double-blind Phase 3 trial involving about 300 participants who will be assigned treatment based on the presence or absence of the DGM1 biomarker.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, constipation or diarrhea from Temozolomide; headaches, dizziness or sleep problems from Enzastaurin; skin irritation from radiotherapy; and general risks like infection due to lowered immunity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and expected to live more than 12 weeks.
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My glioblastoma tumor tissue is available for testing and its MGMT status is known.
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I am mostly able to care for myself and carry out daily activities.
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I am a man considered sterile following a confirmed vasectomy.
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I agree not to use Optune® therapy.
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I was enrolled in the study within 6 weeks after my cancer surgery.
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My surgery site on my head has healed well without any infection.
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My DGM1 biomarker status is known before being assigned to a treatment group.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I agree not to donate semen during and for 6 months after my temozolomide treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZActive Control3 Interventions
Radiotherapy (RT) plus temozolomide (TMZ) and enzastaurin (ENZ) (Concurrent Phase) followed by enzastaurin alone (Single-Agent Phase), then temozolomide and enzastaurin (Adjuvant Phase)
Group II: RT plus TMZ and placebo; placebo; TMZ and placeboPlacebo Group3 Interventions
Radiotherapy (RT) plus temozolomide (TMZ) and placebo followed placebo then by temozolomide and placebo
Find a Location
Who is running the clinical trial?
Denovo Biopharma LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and expected to live more than 12 weeks.My liver is functioning properly.I am currently being treated for a serious infection.My kidney function is normal.I have a serious heart rhythm problem or need a pacemaker to control my slow heartbeat.My glioblastoma tumor tissue is available for testing and its MGMT status is known.I am mostly able to care for myself and carry out daily activities.My corticosteroid dose has been stable or decreasing for the last 5 days.I have chronic hepatitis C confirmed by a positive HCV RNA test.I have had radiation therapy to my brain.I cannot stop taking warfarin for the study.I do not have any health conditions that prevent me from taking temozolomide.I am a man considered sterile following a confirmed vasectomy.My brain tumor is a newly diagnosed glioblastoma, not previously treated with chemo or radiation.I agree not to use Optune® therapy.I was enrolled in the study within 6 weeks after my cancer surgery.I have no other cancers except for non-melanoma skin cancer or any cancer I've been free of for over 5 years.You have a serious medical or mental health condition that could make participating in the study risky or affect the study results.My surgery site on my head has healed well without any infection.My organs are functioning well, as tested within the last 14 days.My hemoglobin level is at least 10 g/dL, possibly after a transfusion.I agree to use birth control during and up to 3-6 months after the study.I am not of reproductive potential due to surgery, confirmed ovarian failure, or being postmenopausal.I cannot swallow pills.My glioblastoma is IDH mutant.My DGM1 biomarker status is known before being assigned to a treatment group.I have tested positive for hepatitis B.I haven't taken any medication that affects heart rhythm in the last week.You or someone in your family has a history of abnormal heart rhythms or fainting spells, or your electrocardiogram (ECG) shows a prolonged QT interval.My kidney function, measured by creatinine levels or clearance, is within the normal range.I agree not to donate semen during and for 6 months after my temozolomide treatment.I cannot stop taking seizure medication, or I stopped them more than 2 weeks ago.I haven't had a heart attack or heart surgery in the last 6 months and don't need treatment for heart failure.I have had treatments like chemotherapy or immunotherapy for brain cancer before.I haven't taken drugs that strongly affect liver enzymes recently.
Research Study Groups:
This trial has the following groups:- Group 1: RT plus TMZ and placebo; placebo; TMZ and placebo
- Group 2: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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