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OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion pushed from Nov 2026 to Dec 31, 2026
    • Interventions: OKN 007 (Drug), Photon/Proton IMRT (Radiation), Temozolomide (Drug) to OKN 007 (Drug), Photon/Proton IMRT (Radiation), Temozolomide (Drug)
    • Eligibility criteria expanded, about 12 words
  2. Re-verified, no change to tracked fieldsv15
  3. Primary completion date changed from estimate of Apr 2025 to Dec 23, 2020v14
  4. Primary completion date: Apr 2024 to Apr 2025
    • Study completion date: Nov 2025 to Nov 2026
    v13
  5. 2 versions Re-verified since Nov 8, 2023, no change to tracked fieldsv11-v12
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv10 Show 4 more changesShow less
    • Enrollment target: estimated 6 to confirmed 27
    • Primary completion date: Dec 2023 to Apr 2024
    • Study completion date: Jun 2025 to Nov 2025
    • Site details revised
  2. Primary completion date: Jun 30, 2023 to Dec 2023
    • Study completion date: Jun 30, 2025 to Jun 2025
    v9
  3. 2 versions Re-verified since May 5, 2021, no change to tracked fieldsv7-v8
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v6
  5. Re-verified, no change to tracked fieldsv5
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2018 to Sep 3, 2018
    v3
  8. Start date: Jul 30, 2018 to Oct 1, 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Oklahoma
162 trials monitored
See 9 trials at risk
Glioma
1,251 trials monitored
See 88 trials at risk
Glioblastoma
710 trials monitored
See 52 trials at risk
This is a pilot study exploring the potential benefit of adding OKN-007 with Temozolomide for treatment in patients with malignant Glioblastoma undergoing adjuvant concomitant radiotherapy. This drug combination is expected to have an anti-cancer effect in patients who have experienced disease progression after first line treatment.
Trial Details
NCT Number NCT03587038
Lead Sponsor University of Oklahoma
Conditions
(from sponsor)		 Glioblastoma
Related terms Glioblastoma
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov