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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Jul 2029 to Jul 2027v14
  2. Primary completion date: Mar 2026 to Jul 2027 Completion date: Mar 2027 to Jul 2029v13 Show 1 more changeShow less
    • Completion date: Mar 2027 to Jul 2029
  3. Primary endpoints revised (3) Enrollment target: 18 to 24 · Secondary endpoints revised (8) · Study description expanded, about 115 words · 1 morev12 Show 4 more changesShow less
    • Enrollment target: 18 to 24
    • Secondary endpoints revised (8)
    • Study description expanded, about 115 words
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria shortened, about 34 wordsv11 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Mar 1, 2026 to Mar 2026 Completion date: Mar 1, 2027 to Mar 2027v10 Show 1 more changeShow less
    • Completion date: Mar 1, 2027 to Mar 2027
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Feb 2025 to Mar 1, 2026 Completion date: Jun 2027 to Mar 1, 2027v9 Show 1 more changeShow less
    • Completion date: Jun 2027 to Mar 1, 2027
  2. Re-verified, no change to tracked fieldsv8
  3. Study description shortened, about 1 wordv7 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Feb 2024 to Feb 2025 Primary endpoints revised (3) · Completion date: Jun 2026 to Jun 2027 · Eligibility criteria expanded, about 16 words · 2 morev6 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Completion date: Jun 2026 to Jun 2027
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints revised (3) Secondary endpoints revised (8) · Site contact updatedv5 Show 2 more changesShow less
    • Secondary endpoints revised (8)
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: May 2024 to Feb 2024 · Completion date: Sep 2026 to Jun 2026 · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: May 2024 to Feb 2024
    • Completion date: Sep 2026 to Jun 2026
    • Start date changed from estimate of Sep 2023 to Jun 26, 2023
  8. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Nebraska
110 trials monitored
See 13 trials at risk
Glioblastoma
670 trials monitored
See 44 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT05698524
Lead Sponsor University of Nebraska
Collaborators: Xynomic Pharmaceuticals, Inc.
Conditions Recurrent High Grade Glioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Glioblastoma, Gliosarcoma
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov