Actively Recruiting
An Open-label, Phase 1b Study Evaluating Safety and Tolerability of Eflornithine Plus Temozolomide in Newly Diagnosed Glioblastoma or Astrocytoma
Led by Orbus Therapeutics, Inc. · Updated on 2025-06-25
66
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the recommended phase 2 dose of eflornithine combined with temozolomide in patients newly diagnosed with glioblastoma or astrocytoma. This phase 1b open-label study aims to assess the safety and tolerability of this drug combination. The study is sponsored by Orbus Therapeutics, Inc., and involves patients with newly diagnosed brain tumors classified by the World Health Organization. Participants will receive escalating doses of eflornithine along with a standard dose of temozolomide. Eflornithine is given orally every 8 hours on a schedule of 2 weeks on treatment followed by 2 weeks off, with doses of 1.75, 2.3, or 2.8 g/m2 under evaluation. Temozolomide is taken orally once daily for 5 days followed by 23 days off. The study includes a dose escalation phase followed by an expansion cohort to further assess safety and early effectiveness of the combination at the recommended dose. Participants will be involved for up to approximately 104 weeks, including screening lasting up to 4 weeks, the treatment period, and a follow-up visit 4 weeks after treatment ends. Long-term survival follow-up will continue for up to 2 years after last treatment. Researchers will monitor dose limiting toxicities, treatment-emergent adverse events, vital signs, laboratory test abnormalities, and pharmacokinetics. They will also assess overall survival, progression-free survival, and response rates to evaluate the drug combination.
CONDITIONS
Brief Title
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of WHO Grade 4 glioblastoma, IDH-wildtype, or Grade 3 astrocytoma with IDH1 or IDH2 mutation and CDKN2A/B intact per WHO 2021 classification
- Completed external beam radiation therapy according to standard care
- For glioblastoma patients: received at least 80% of planned daily temozolomide doses during chemoradiation
- For astrocytoma patients: tolerated 2 to 4 cycles of adjuvant temozolomide
- Adequate blood counts, kidney, liver, and organ function shown by lab tests
- Willing to abstain from intercourse or use acceptable contraceptive methods
- If using corticosteroids, dose must be stable or decreasing
You will not qualify if you...
- Recent history of recurrent or metastatic cancer that may affect study results
- Prior systemic chemotherapy other than temozolomide during radiation or up to 4 cycles of adjuvant temozolomide
- Previous treatment with Optune device
- Active infection or serious medical illness
- Poorly controlled seizures
- Significant heart disease within 6 months before enrollment
- Poorly controlled diabetes
- Use of another investigational drug within 30 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to approximately 104 weeks
Participants receive escalating doses of eflornithine plus temozolomide according to the study schedule and dose level assigned.
Visits occur regularly during treatment according to dosing schedules
Duration - 4 weeks
Participants are monitored for safety and adverse events for 4 weeks after the last treatment dose.
1 follow-up visit
Duration - Up to 2 years
Participants are followed for overall survival outcomes up to 2 years from the last treatment.
Periodic survival status assessments
Trial Site Locations
Total: 8 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
3
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States, 10032
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
5
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
Brown University Health/Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
M
Monika Varga
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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