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OncoMatch/Clinical Trials/NCT05698524

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

Is NCT05698524 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PCI 24781 and Temozolomide for recurrent high grade glioma.

Phase 1RecruitingUniversity of NebraskaNCT05698524Data as of May 2026

Treatment: PCI 24781 · TemozolomideGlioblastoma (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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage III, IV (WHO grade)

Grade: IIIIV (WHO)

high grade (aka grade III or IV) glioma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: radiation therapy

Prior radiation therapy

Must have received: cytotoxic chemotherapy (temozolomide) — standard

standard temozolomide

Lab requirements

Blood counts

ANC count ≥1,500/mm3, hemoglobin > 8 g/dL, platelet count ≥100,000/mm3

Kidney function

serum creatinine that is at or below 2.0 mg/dL

Liver 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

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Nebraska Medical Center · Omaha, Nebraska

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