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

NCT05698524 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-17

No results posted yet for this study

Summary

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. 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.

Conditions

  • Recurrent High Grade Glioma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Glioblastoma
  • Gliosarcoma

Interventions

DRUG

PCI 24781

Participants will take PCI-24781/Abexinostat on days 1 - 4, 8 - 11, and 15 - 18 of each 28-day cycle.

DRUG

Temozolomide

Participants will receive temozolomide at a dose of 50 mg/mg2, taken by mouth once daily.

Sponsors & Collaborators

  • Xynomic Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Nicole A Shonka, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2027-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698524 on ClinicalTrials.gov