Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
1 other identifier
interventional
66
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 25, 2025
June 1, 2025
2.9 years
May 3, 2023
June 19, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Assessment of Dose Limiting Toxicities
Protocol Defined Dose Limiting Toxicities
8 weeks
Incidence of TEAEs All Grades
All Grades
From enrollment to the follow-up visit 4 weeks after end of treatment
Incidence of TEAEs Grade 3+
Grade 3+
From enrollment to the follow-up visit 4 weeks after end of treatment
Incidence of TEAEs Serious
Serious
From enrollment to the follow-up visit 4 weeks after end of treatment
Incidence of TEAEs Leading to Discontinuation
Leading to Discontinuation
From enrollment to the end of treatment
Vital Signs (Heart and Respiratory Rate)
Change from Baseline in Heart Rate and Respiratory Rate
From enrollment to the follow-up visit 4 weeks after end of treatment
Vital Signs (Blood Pressure)
Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
From enrollment to the follow-up visit 4 weeks after end of treatment
Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests
Lab abnormalities by CTCAE v5.0 Grade
From enrollment to the follow-up visit 4 weeks after end of treatment
Secondary Outcomes (11)
Overall Survival
From enrollment to up to 2 years after last dose
Progression Free Survival
From enrollment to the follow-up visit 4 weeks after end of treatment
Overall Response Rate
From enrollment to the follow-up visit 4 weeks after end of treatment
Pharmacokinetics Cmax
Baseline to Steady State (2 weeks)
Pharmacokinetics Cmin
Baseline to Steady State (2 weeks)
- +6 more secondary outcomes
Study Arms (3)
Eflornithine Dose Level 1 + Temozolomide
EXPERIMENTALEflornithine Dose Level 2 + Temozolomide
EXPERIMENTALEflornithine Dose Level -1 + Temozolomide
EXPERIMENTALInterventions
Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
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
Eligibility Criteria
You 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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27710, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Brown University Health/Rhode Island Hospital
Providence, Rhode Island, 02903, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Colman, MD, PhD
Huntsman Cancer Institute/ University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 30, 2023
Study Start
July 24, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share