New combo aims to tackle aggressive brain tumors that have come back
NCT ID NCT05698524
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This early-phase study tests a new two-drug combination for adults whose high-grade glioma (a fast-growing brain tumor) has returned after standard treatment. The drugs are temozolomide (a chemotherapy pill given daily at low doses) and abexinostat (an experimental drug that may help the chemo work better). The main goals are to find the safest dose and to track side effects in 24 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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Other studies related to the condition(s) this trial covers.
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