Trial Title:
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
NCT ID:
NCT05879367
Condition:
Glioblastoma, IDH-wildtype
Glioblastoma
Glioblastoma Multiforme
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
GBM
Conditions: Official terms:
Glioblastoma
Eflornithine
Temozolomide
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Eflornithine (Dose Level 1)
Description:
Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off
schedule
Arm group label:
Eflornithine Dose Level 1 + Temozolomide
Other name:
DFMO
Intervention type:
Drug
Intervention name:
Eflornithine (Dose Level 2)
Description:
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off
schedule
Arm group label:
Eflornithine Dose Level 2 + Temozolomide
Other name:
DFMO
Intervention type:
Drug
Intervention name:
Eflornithine (Dose Level -1)
Description:
Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off
schedule
Arm group label:
Eflornithine Dose Level -1 + Temozolomide
Other name:
DFMO
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
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
Arm group label:
Eflornithine Dose Level -1 + Temozolomide
Arm group label:
Eflornithine Dose Level 1 + Temozolomide
Arm group label:
Eflornithine Dose Level 2 + Temozolomide
Other name:
Temodar
Other name:
TMZ
Summary:
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.
Detailed description:
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).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thiru Pillay
Phone:
205-934-1432
Email:
Tpillay@uabmc.edu
Investigator:
Last name:
Louis B Nabors, MD
Email:
Principal Investigator
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meghan Gauronskas
Phone:
313-725-7871
Email:
mgauron1@hfhs.org
Contact backup:
Last name:
Angela Dunn
Phone:
313-725-7870
Email:
adunn6@hfhs.org
Investigator:
Last name:
Tobias Walbert, MD, PhD, MPH
Email:
Principal Investigator
Facility:
Name:
Columbia University Medical Center - Herbert Irving Pavilion
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Diaz, MD
Phone:
212-342-0571
Email:
md4157@cumc.columbia.edu
Contact backup:
Last name:
Alicia Bargo
Phone:
212-342-4435
Email:
ab5172@cumc.columbia.edu
Investigator:
Last name:
Maria Diaz, MD
Email:
Principal Investigator
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Severance
Phone:
919-668-6230
Email:
erin.k.bell@duke.edu
Investigator:
Last name:
Annick Desjardins, MD, FRCPC
Email:
Principal Investigator
Facility:
Name:
The Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Peereboom, MD
Phone:
216-445-6068
Email:
peerebd@ccf.org
Contact backup:
Last name:
Rachel Hufsey, RN
Email:
hufseyr@ccf.org
Investigator:
Last name:
David Peereboom, MD
Email:
Principal Investigator
Facility:
Name:
Lifespan Cancer Institute/Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nuno Rodrigues, RN
Phone:
401-444-3059
Email:
908306@Lifespan.org
Contact backup:
Last name:
Francesca Rothell, MS
Phone:
401.606.5488
Email:
frothell@Lifespan.org
Investigator:
Last name:
Eric Wong, MD
Email:
Principal Investigator
Facility:
Name:
UT MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carlos Kamiya Matsuoka, MD
Phone:
713-408-3538
Email:
CKamiya@mdanderson.org
Contact backup:
Last name:
Evguenia Gachimova, RN
Phone:
832-266-3519
Email:
Egachimova@mdanderson.org
Investigator:
Last name:
Carlos Kamiya Matsuoka, MD
Email:
Principal Investigator
Facility:
Name:
University of Utah, Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Kingsford
Phone:
801-585-0115
Email:
rachel.kingsford@hci.utah.edu
Contact backup:
Last name:
Yuri Kida
Phone:
801-646-4397
Email:
yuri.kida@hci.utah.edu
Investigator:
Last name:
Howard Colman, MD, PhD
Email:
Principal Investigator
Start date:
July 24, 2023
Completion date:
December 15, 2024
Lead sponsor:
Agency:
Orbus Therapeutics, Inc.
Agency class:
Industry
Source:
Orbus Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05879367
