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Enzastaurin + Temozolomide for Glioblastoma
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 may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: RT plus TMZ and placebo; placebo; TMZ and placebo
- Group 2: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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