What side effects are associated with this type of intervention?

Common treatments for glioblastoma, such as temozolomide and radiation therapy, often result in side effects including fatigue, nausea, vomiting, and hematologic toxicities like neutropenia and thrombocytopenia. Novel treatments targeting molecular pathways, such as Enzastaurin, may also cause gastrointestinal disturbances, liver enzyme abnormalities, and potential cardiovascular effects. Additionally, scalp cooling used to mitigate alopecia during chemotherapy can lead to headaches, scalp pain, and a sensation of cold. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

Temozolomide is an FDA-approved oral chemotherapy drug commonly used in the treatment of glioblastoma, particularly in combination with radiation therapy. It works by alkylating/methylating DNA, which leads to tumor cell death. Bevacizumab, an anti-VEGF monoclonal antibody, is another FDA-approved treatment for recurrent glioblastoma, targeting angiogenesis to inhibit tumor growth. Additionally, targeted therapies like sotorasib and adagrasib, which inhibit specific molecular pathways such as the KRAS G12C mutation, have shown promise in other cancers and represent a similar approach to targeting molecular pathways in glioblastoma.

What other types of research exist?

Promising novel alternatives for glioblastoma treatment in 2024 include: 1) Enzastaurin plus temozolomide during and following radiation therapy, which is currently in a Phase 3 trial. 2) Small molecule inhibitors targeting IDH1/2 mutations, such as ivosidenib and vorasidenib, which have shown efficacy in clinical trials. 3) Anti-angiogenic therapies targeting VEGF pathways, such as bevacizumab, which can manage symptomatic edema and potentially improve outcomes when combined with other treatments. 4) Immunotherapy approaches, including immune checkpoint inhibitors like nivolumab, which have shown promise in recurrent high-grade gliomas.

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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

Must not have

Active bacterial, fungal or viral infection requiring systemic treatment

History of significant cardiac arrhythmia (ventricular tachycardia or fibrillation, Torsades de Pointe) or second- or third-degree A-V block, symptomatic bradycardia (unless controlled with a pacemaker)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests a new treatment in patients with newly diagnosed glioblastoma to see if it works better than current options.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for a serious infection.

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I have a serious heart rhythm problem or need a pacemaker to control my slow heartbeat.

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I have chronic hepatitis C confirmed by a positive HCV RNA test.

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I have had radiation therapy to my brain.

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I cannot stop taking warfarin for the study.

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I do not have any health conditions that prevent me from taking temozolomide.

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I cannot swallow pills.

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My glioblastoma is IDH mutant.

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I have tested positive for hepatitis B.

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I haven't taken any medication that affects heart rhythm in the last week.

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I haven't had a heart attack or heart surgery in the last 6 months and don't need treatment for heart failure.

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I haven't taken drugs that strongly affect liver enzymes recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Glioblastoma include temozolomide and angiogenesis inhibitors. Temozolomide is an oral chemotherapy drug that works by methylating DNA, which leads to tumor cell death. Angiogenesis inhibitors, such as bevacizumab, target the vascular endothelial growth factor (VEGF) pathway to inhibit the formation of new blood vessels that tumors need to grow. These treatments are crucial for Glioblastoma patients as they aim to reduce tumor growth and improve survival rates by targeting specific molecular pathways involved in tumor proliferation and maintenance.

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Who is running the clinical trial?

Denovo Biopharma LLCLead Sponsor

17 Previous Clinical Trials

2,820 Total Patients Enrolled

1 Trials studying Glioblastoma

33 Patients Enrolled for Glioblastoma

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03776071 — Phase 3

Glioblastoma Research Study Groups: RT plus TMZ and placebo; placebo; TMZ and placebo, RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ

Glioblastoma Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT03776071 — Phase 3

Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03776071 — Phase 3

~55 spots leftby Oct 2025

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