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Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

Study Purpose

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification.

- Completed external beam radiation therapy per standard of care.

- Must have received at least 80% of planned daily doses of TMZ during chemoradiation.

- Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.

- Willing to abstain from intercourse or use acceptable contraceptive methods.

- If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria:

- Recent history of recurrent or metastatic cancer that could confound response assessments.

- Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation therapy.

- Prior Optune treatment.

- Active infection or serious intercurrent medical illness.

- Poorly controlled seizures.

- Significant cardiac disease within 6 months of enrollment.

- Poorly controlled diabetes.

- Use of another investigational agent within 30 days of enrollment.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05879367
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Orbus Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Howard Colman, MD, PhD
Principal Investigator Affiliation	Huntsman Cancer Institute/ University of Utah
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, GBM

Additional Details

This open label dose escalation and expansion study will be conducted using a standard dose-escalation design with escalating doses of eflornithine plus temozolomide at the approved dose level, followed by an expansion cohort that will further evaluate safety and preliminary efficacy of the combination at the recommended phase 2 dose. Duration of participation will be up to 56 weeks in total per patient: Screening Period

- A maximum screening duration of 4 weeks.

Treatment Period

- Up to 48 weeks.

Follow-Up Visit

- 4 weeks from last treatment.

A total of up to 66 patients will be enrolled in a non-randomized fashion (patients may be added to any of the dose levels below the RP2D to a maximum of approximately 20 per dose level with the intent of further characterizing safety and pharmacokinetics).

Arms & Interventions

Arms

Experimental: Eflornithine Dose Level 1 + Temozolomide

Experimental: Eflornithine Dose Level 2 + Temozolomide

Experimental: Eflornithine Dose Level -1 + Temozolomide

Interventions

Drug: - Eflornithine (Dose Level 1)

Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Drug: - Eflornithine (Dose Level 2)

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Drug: - Eflornithine (Dose Level -1)

Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Drug: - Temozolomide

Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Thiru Pillay

[email protected]

205-934-1432

Henry Ford Hospital, Detroit, Michigan

Status