Actively Recruiting
A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
Led by University of Nebraska · Updated on 2026-04-17
24
Participants Needed
1
Research Sites
313 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
Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.
CONDITIONS
Official Title
A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high grade (grade III or IV) glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, or gliosarcoma
- Previous radiation therapy and standard temozolomide chemotherapy; additional prior therapies allowed
- At least 3 months since end of chemoradiotherapy or biopsy/imaging shows disease progression
- Age 19 years or older
- Fully recovered from side effects of previous treatments that could affect study drug tolerance
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate bone marrow function (ANC 61500/mm3, hemoglobin > 8 g/dL, platelets 61100,000/mm3)
- Adequate kidney function (serum creatinine 612.0 mg/dL)
- Adequate liver function (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 study
- Females of reproductive potential must use effective birth control during and up to 6 months after treatment
You will not qualify if you...
- Any life-threatening illness or medical condition that could affect safety or drug absorption
- Significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, myocardial infarction within 6 months, or severe heart disease
- Malabsorption syndrome or significant gastrointestinal disease or surgery
- Use of immunotherapy, chemotherapy, radiotherapy, corticosteroids (> prednisone 20 mg/day), or experimental therapy within 4 weeks before study drug
- Current use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate, oxcarbazepine)
- Any other active cancer except nonmelanoma skin cancer or controlled prostate cancer
- Known HIV infection or active hepatitis B or C infection or uncontrolled active infection
- Creatinine above 1.5 times upper limit of normal, total bilirubin above 1.5 times upper limit (unless Gilbert's disease), AST or ALT above 2.5 times upper limit
- Pregnant or breastfeeding
- QTc interval prolongation on ECG over 450 ms in males or 470 ms in females
- Use of valproic acid or other histone deacetylase inhibitors
- Taking certain medications that cannot be stopped or switched before enrollment including amiodarone, arsenic trioxide, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, droperidol, erythromycin, flecainide, haloperidol, ibutilide, methadone, moxifloxacin, pentamidine, pimozide, procainamide, quinidine, sotalol, thioridazine, vandetanib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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