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Anti-cancer agent
Eflornithine + Temozolomide for Glioblastoma
Phase 1
Recruiting
Led By Howard Colman, MD, PhD
Research Sponsored by Orbus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial tests a new drug combo to treat newly-diagnosed glioblastoma to see if it's safe & effective.
Who is the study for?
This trial is for adults with a specific brain cancer called glioblastoma (GBM), IDH-wildtype, who have finished radiation therapy and most of their initial chemo with temozolomide. They need good blood, kidney, liver function and agree to use birth control. It's not for those with recent serious heart issues, uncontrolled diabetes or other cancers, active infections, prior Optune treatment or poorly controlled seizures.Check my eligibility
What is being tested?
The study tests different doses of Eflornithine in combination with Temozolomide to find the safest and most effective dose for treating newly diagnosed GBM patients. The goal is also to check how well patients tolerate this drug combo.See study design
What are the potential side effects?
Possible side effects include typical reactions from chemotherapy like nausea, vomiting, fatigue, hair loss and increased risk of infection due to lowered white blood cell counts. Specific side effects related to Eflornithine are not detailed but may be similar.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Dose Limiting Toxicities
Incidence of TEAEs All Grades
Incidence of TEAEs Grade 3+
+5 moreSecondary outcome measures
Assessment of QTcF
Overall Response Rate
Pharmacokinetics AUCt
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Eflornithine Dose Level 2 + TemozolomideExperimental Treatment2 Interventions
Group II: Eflornithine Dose Level 1 + TemozolomideExperimental Treatment2 Interventions
Group III: Eflornithine Dose Level -1 + TemozolomideExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
Orbus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
343 Total Patients Enrolled
Howard Colman, MD, PhDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
1 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have finished my external beam radiation therapy as recommended.I have previously been treated with Optune.I do not have any serious infections or illnesses right now.I do not have a recent history of cancer that could affect response assessments.I have received chemotherapy for brain cancer, but only temozolomide during radiation.My diabetes is not well-managed.I have not had serious heart problems in the last 6 months.I took at least 80% of my prescribed TMZ doses during my treatment.I have frequent and uncontrolled seizures.My blood, kidney, liver, and other organs are functioning well according to tests.I am on a stable or decreasing dose of corticosteroids.My brain tumor is a Grade 4 glioblastoma and is not IDH mutated.
Research Study Groups:
This trial has the following groups:- Group 1: Eflornithine Dose Level 2 + Temozolomide
- Group 2: Eflornithine Dose Level -1 + Temozolomide
- Group 3: Eflornithine Dose Level 1 + Temozolomide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for this experiment that participants can join?
"Yes, the trial is actively recruiting, as can be seen on clinicaltrials.gov. It was initially made available to patients on May 26th 2023 and was last revised on May 19th of the same year."
Answered by AI
Has the FDA sanctioned Eflornithine Dose Level 1 and Temozolomide in combination?
"Our team at Power estimated the safety of Eflornithine Dose Level 1 + Temozolomide to be a score of one due to this being an initial Phase 1 trial. Thus, there is limited data available regarding its efficacy and security."
Answered by AI
What is the upper limit of participants for this experiment?
"Yes, as outlined on clinicaltrials.gov the trial is recruiting participants. The protocol was launched on May 26th 2023 and has been updated recently on 19th of May 2023. Currently, only 1 site needs to fill 60 positions for this study."
Answered by AI
What is the objective of this research initiative?
"Orbus Therapeutics, Inc., the study's sponsor has identified a 8-week interval as the primary means of assessing their key objective: documenting Adverse Events. Secondary objectives include measuring Overall Response Rate (as assessed by MRI) Pharmacokinetics Cmax (observed maximum concentration), and Pharmacokinetics Cmin (observed minimum concentration)."
Answered by AI
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