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New combo aims to tackle aggressive brain tumors that have come back

NCT ID NCT05698524

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

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Other studies related to the condition(s) this trial covers.