What this study is
The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
What's being tested
- Eflornithine (Dose Level 1)
Intervention · DRUG
Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Eflornithine (Dose Level 2)
Intervention · DRUG
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Eflornithine (Dose Level -1)
Intervention · DRUG
Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
- Temozolomide
Intervention · DRUG
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
Study details
- Official title
- An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
- Sponsor
- Orbus Therapeutics, Inc.
- Conditions
- Glioblastoma, IDH-wildtype · Glioblastoma · Glioblastoma Multiforme · Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype · GBM · Astrocytoma · Astrocytoma, IDH-Mutant
- Enrolling
- 66 people
- Starts
- 2023-07-24
- Est. completion
- 2026-06-30
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.
- Completed external beam radiation therapy per standard of care.
- Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.
- 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.
You can't join if
- Recent history of recurrent or metastatic cancer that could confound response assessments
- Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
7 openHenry Ford Hospital
Detroit, Michigan, United States
- Meghan Gauronskas · Contact313-725-7871mgauron1@hfhs.org
- Angela Dunn · Contact313-725-7870adunn6@hfhs.org
- Tobias Walbert, MD, PhD, MPH · Principal investigator
RecruitingColumbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
- Maria Diaz, MD · Contact212-342-0571md4157@cumc.columbia.edu
- Nurse Navigators · Contact212-342-5162cancerclinicaltrials@cumc.columbia.edu
- Maria Diaz, MD · Principal investigator
RecruitingDuke University
Durham, North Carolina, United States
- Erin Severance · Contact919-668-6230erin.k.bell@duke.edu
- Annick Desjardins, MD, FRCPC · Principal investigator
RecruitingThe Cleveland Clinic
Cleveland, Ohio, United States
- David Peereboom, MD · Contact216-445-6068peerebd@ccf.org
- Rachel Hufsey, RN · Contacthufseyr@ccf.org
- David Peereboom, MD · Principal investigator
RecruitingBrown University Health/Rhode Island Hospital
Providence, Rhode Island, United States
- Nuno Rodrigues, RN · Contact401.444.3059Nuno.Rodrigues@brownhealth.org
- Gada Alam · Contact401-444-6217GAlam@brownhealth.org
- Eric Wong, MD · Principal investigator
RecruitingUT MD Anderson Cancer Center
Houston, Texas, United States
- Carlos Kamiya Matsuoka, MD · Contact713-408-3538CKamiya@mdanderson.org
- Evguenia Gachimova, RN · Contact832-266-3519Egachimova@mdanderson.org
- Carlos Kamiya Matsuoka, MD · Principal investigator
RecruitingUniversity of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
- Rachel Kingsford · Contact801-585-0115rachel.kingsford@hci.utah.edu
- Yuri Kida · Contact801-646-4397yuri.kida@hci.utah.edu
- Howard Colman, MD, PhD · Principal investigator
RecruitingUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
Withdrawn
Study team
Sponsor
Orbus Therapeutics, Inc.
Study ID OT-21-101
Principal investigator
Howard Colman, MD, PhD
Huntsman Cancer Institute/ University of Utah
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.