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Study of Temodar with Abexinostat for Recurrent Glioma

This study is testing a new combination treatment for recurrent high-grade glioma, including glioblastoma, anaplastic astrocytoma, and anaplastic oligodendroglioma. It combines two drugs: Temozolomide (Temodar), a chemotherapy drug you might already be familiar with, and Abexinostat (PCI-24781). Researchers want to find the safest and most effective dose of Abexinostat when given with Temozolomide. They will be looking closely at any side effects that occur over about two years. You may be eligible if you have a high-grade glioma that has come back after previous treatments like radiation and standard Temozolomide. The study plans to enroll 24 participants.

Study design
This is an interventional study that plans to enroll 24 participants. It is not specified if it is randomized or blinded.
What's involved
You would take Abexinostat on specific days for three weeks out of each 28-day cycle, and Temozolomide once daily by mouth. Treatment continues until your disease progresses or side effects become too severe.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor side effects for up to 25 months. The recommended dose will be determined within 20 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05698524

A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma

Recruiting
PHASE1Ages 19+InterventionalTreatment
University of Nebraska
~24 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:PCI 24781Temozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Toxicities Associated with PCI-24781/Abexinostat and Metronomic Temozolomide Therapy - Adverse Events and Serious Adverse Events
Measured over Up to 25 months
+2 more outcomes measured

Conditions

Recurrent High Grade Glioma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Glioblastoma
Gliosarcoma

Explore related trials

Anaplastic AstrocytomaAnaplastic OligodendrogliomaGlioblastomaGliosarcomaMalignant Glioma

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Nicole A Shonka, MD · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

Michaela K Savine, RN
[email protected]
402-836-9488
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma)
Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are allowed)
Three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression
19 years of age or older (the age of consent in Nebraska)
Fully recovered from any toxicity of prior therapy that, in the opinion of the investigator, could impact tolerance to the study drug
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate bone marrow reserve (ANC count ≥1,500/mm3, hemoglobin \> 8 g/dL, platelet count ≥100,000/mm3)
Adequate renal function (a serum creatinine that is at or below 2.0 mg/dL)
Adequate hepatic function (serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline phosphatase less than 2.5 times the upper limits of normal)
Able to provide written, informed consent
Females of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries)
Females of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and up to 6 months following treatment

Exclusion

Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-24781/Abexinostat, or put the study outcomes at undue risk
Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) or experimental therapy (other than PCI-24781/Abexinostat PO) within 4 weeks before first dose of study drug
Concurrent use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate and oxcarbazepine)
Any other active malignancy other than nonmelanoma skin cancer or controlled prostate cancer
Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection (no testing is required for eligibility)
Creatinine \> 1.5 x institutional upper limit of normal (ULN); total bilirubin \> 1.5 x ULN (unless from Gilbert's disease), and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN
Pregnant or breast-feeding
Baseline ECG duration of the ventricular action potential corrected for heart rate (QTc interval) prolongation based on Fridericia's formula is \> 450 ms in males and \> 470 ms in females
Concomitant valproic acid use, or another histone deacetylases (HDAC) inhibitor
Receiving treatment with following medications and unable to discontinue treatment or switch medications prior to study enrollment:
Amiodarone (Cordarone, Pacerone)
Arsenic trioxide (Trisenox)
Chlorpromazine (Aralen)
Cisapride (Propulsid)
Clarithromycin (Biaxin)
Disopyramide (Norpace)
Dofetilide (Tikosyn)
Doperidol (Inapsine)
Erythromycin (EryTab, Erythrocin)
Flecanide (Tambocor)
Haloperidol (Haldol)
Ibutilide (Corvert)
Methadone (Methadose, Dolophine)
Moxifloxacin (Avelox)
Pentamidine (Pentam, Nebupent)
Pimozide (Orap)
Procainamide (Procan, Pronestyl)
Quinidine (Cardioquin, Quinaglute)
Sotalol (Betapace)
Thioridazine (Mellaril)
Vandetanib (Zactima)

What this trial measures

  • Toxicities Associated with PCI-24781/Abexinostat and Metronomic Temozolomide Therapy - Adverse Events and Serious Adverse EventsUp to 25 months

    The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded for each dose level cohort. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on from 1 to 5, with higher numbers indicating a higher severity grade.

  • Toxicities Associated With PCI-24781/Abexinostat and Metronomic Temozolomide Therapy - OverallUp to 25 months

    The frequency of overall toxicity occurrence will be categorized by toxicity grades using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded ranging from 1 to 5, with higher numbers indicating a higher severity grade.

  • Recommended Dose Determination of PCI-24781/AbexinostatUp to 20 months

    Participants who either complete the first cycle of treatment or experience a dose-limiting toxicity (DLT) within the first cycle of treatment will be considered evaluable. The target DLT rate for the maximum tolerated dose (MTD) is 0.25. The MTD determination will be based on isotonic regression. The MTD will be defined as the dose for which the isotonic estimate of the DLT rate is closest to the target DLT rate of 0.25. If a tie exists between potential doses the higher dose level will be selected when the isotonic estimate is lower than the target DLT rate and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target DLT rate. If the observed DLT rate at the current dose is ≤ 0.197, escalate the dose to the next higher dose level. If the observed DLT rate at the current dose is \> 0.298, de-escalate the dose to the next lower dose level. Otherwise, stay at the current dose level.