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RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ for Glioblastoma

Tianjin Huanhu Hospital, Jinnan, China
Temozolomide +3 morePhase 3Waitlist AvailableResearch Sponsored by Denovo Biopharma LLC

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.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are able to perform daily activities with a good level of energy and independence.
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You agree not to use Tumor Treating Fields therapy (Optune®) during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 site

Who is running the clinical trial?

Denovo Biopharma LLCLead Sponsor

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new participants in this trial?

"As of right now, this study is not recruiting patients. The last time this information was updated was on October 11th, 2022. There are currently 458 clinical trials actively looking for participants with glioblastoma and 219 studies for RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ actively admitting participants."

Answered by AI

What are RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ used to treat?

"The conventionally accepted treatment for nitrosourea is a combination of RT, TMZ, and ENZ. Additionally, this treatment can be used to manage a variety of other conditions including advance directives, refractory, advanced mycosis fungoides, and refractory neuroblastoma."

Answered by AI

What are the risks associated with the combined use of RT, TMZ, and ENZ; ENZ alone; and TMZ and ENZ?

"This treatment, which is currently in Phase 3 clinical trials, has received a score of 3 for safety. This is due to the presence of both efficacy data and multiple rounds of safety data."

Answered by AI

Are there other ongoing trials that study the combination of RT plus TMZ and ENZ, ENZ by itself, or TMZ and ENZ together?

"18,676 completed trials studying the effects of RT plus TMZ and ENZ; ENZ alone; and TMZ and ENZ have been completed since the initial 2002 study at Memorial Sloan Kettering Cancer Center. As of now, 219 trials are actively recruiting patients, with a high concentration of these clinical studies taking place in San Diego, California."

Answered by AI

What makes this test group unique?

"Since 2002, researchers have been studying the effects of RT plus TMZ and ENZ; ENZ alone; and TMZ and ENZ. The first study was conducted in 2002 and was sponsored by Schering-Plough. After the initial trial, which involved 60 patients, RT plus TMZ and ENZ; ENZ alone; and TMZ and ENZ received its Phase 2 drug approval. Today, there are 219 active studies for RT plus TMZ and ENZ; ENZ alone; and TMZ and ENZ across 947 cities and 34 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1
2020. "A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03776071.
~113 spots leftby Jun 2025
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