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New treatment option for Recurrent High Grade Glioma
Official title A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
ClinicalTrials.gov ID: NCT05698524
What this study is testing
What is PCI 24781?
PCI 24781 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for recurrent high grade glioma.
Also referred to as Abexinostat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma...
- Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are...
- 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
You likely can't join if
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's...
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months...
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis...
- Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) or experimental therapy (other than...
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.