Actively Recruiting
A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma
Led by University of Nebraska · Updated on 2026-04-17
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Nebraska
Lead Sponsor
X
Xynomic Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying recurrent high grade glioma, including glioblastoma and other grade III or IV gliomas, which are aggressive brain tumors with poor survival even after standard treatments like radiation and temozolomide chemotherapy. This study aims to find the recommended dose and assess side effects of combining PCI-24781/Abexinostat with low-dose continuous temozolomide for these recurrent tumors, which currently have limited treatment options and low progression-free survival rates. Participants will be assigned to one of four PCI-24781/Abexinostat dose levels, taken orally twice daily on specific days within each 28-day cycle, alongside metronomic temozolomide at 50 mg/m2 twice daily continuously. The study uses a dose escalation design to find the optimal dose based on early toxicities. Treatment continues until the disease progresses or side effects become intolerable. During the study, participants will undergo assessments including monitoring for adverse events, blood tests to measure drug effects on histone acetylation, tumor response evaluations, and quality of life questionnaires. Researchers will also study pharmacokinetics and molecular markers related to tumor response. Follow-up for progression-free and overall survival will continue for up to 36 months, with safety monitoring lasting up to 25 months.
CONDITIONS
Brief Title
A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically proven diagnosis of high grade (grade III or IV) glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, or gliosarcoma
- Prior radiation therapy and standard temozolomide treatment; other prior therapies allowed
- At least 3 months from the end of chemoradiotherapy or biopsy/imaging showing disease progression
- Age 19 years or older
- Fully recovered from any toxicity of prior therapy that may impact tolerance to study drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate bone marrow reserve with ANC 1,500/mm3, hemoglobin > 8 g/dL, platelet count 100,000/mm3
- Adequate renal function with serum creatinine 2.0 mg/dL or less
- Adequate hepatic function with AST and ALT less than 1.5 times upper limit of normal, alkaline phosphatase less than 2.5 times upper limit
- Able to provide written informed consent
- Females of child-bearing potential must have a negative pregnancy test within 7 days before starting
- Females of reproductive potential must use effective birth control during the study and for 6 months after treatment
You will not qualify if you...
- Any life-threatening illness or medical condition that compromises safety or study outcomes
- Significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, recent myocardial infarction, or severe cardiac disease
- Malabsorption syndrome or gastrointestinal disorders affecting drug absorption
- Use of immunotherapy, chemotherapy, radiotherapy, corticosteroids (>20 mg prednisone equivalent), or experimental therapy within 4 weeks before study drug
- Concurrent use of enzyme-inducing antiepileptic drugs
- Active malignancies other than nonmelanoma skin cancer or controlled prostate cancer
- Known HIV, active Hepatitis B or C infection, or uncontrolled systemic infection
- Creatinine above 1.5 times institutional upper limit; total bilirubin above 1.5 times upper limit (except Gilbert's); AST or ALT above 2.5 times upper limit
- Pregnant or breastfeeding
- Prolonged QTc interval >450 ms in males or >470 ms in females
- Use of valproic acid or other histone deacetylase inhibitors
- Receiving certain medications (listed) that cannot be stopped before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 months or until disease progression or intolerable toxicity
Participants take PCI-24781/Abexinostat and metronomic temozolomide on a repeated 28-day cycle until disease progression or intolerable toxicity.
Visits occur regularly during each 28-day cycle, including days 1 - 4, 8 - 11, and 15 - 18 for PCI-24781/Abexinostat dosing
Duration - Up to 36 months
Participants are followed to evaluate progression-free survival, overall survival, tumor response, quality of life, and other outcomes after treatment ends.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
M
Michaela K Savine, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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