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NCT05432518

Pilot Trial for Treatment of Recurrent Glioblastoma

StatusEnrolling by Invitation
PhaseEarly Phase 1
Primary completion (estimated)
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Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Minor Trial status changed: Recruiting → Enrolling by Invitation Show 4 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
    • Collaborators shortened, about 4 words
  2. Minor Eligibility criteria expanded, about 16 words
    • Study site revised
    v7
  3. Minor Site contact updatedv6
  4. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 5 more changesShow less
    • Primary completion date: Dec 1, 2027 to Jul 1, 2027
    • Start date changed from estimate of Jun 1, 2023 to Jun 27, 2023
    • Site details revised
    • Collaborators expanded, about 4 words
    • Study title expanded, about 4 words
  5. Notable Start date: Sep 1, 2022 to Jun 1, 2023v3
  6. Notable Primary endpoint revised
    • Interventions: Afatinib, Dasatinib, Palbociclib, Everolimus, Olaparib (Drug) to Afatinib (Drug), Dasatinib (Drug), Everolimus (Drug), Olaparib (Drug), Palbociclib (Drug)
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Success rate of personalized GBM treatment based on molecular characterization of recurrent tumor
Timeframe: From date of initial consent to participate to the end of follow up period (24 months)

Secondary (4)

Overall survival (OS)
Progression free survival (PFS)
Quality of Life (QoL) EORTC QLQ-C30
Quality of Life (QoL) EORTC QLQ BN-20

Arms and interventions

TreatmentExperimental

Patients will receive one of the 5 study drugs based on their recurrent tumor mutation profile and their recurrent organoid response to these drugs: 1. Afatinib 2. Dasatinib 3. Palbociclib 4. Everolimus 5. Olaparib

Drugs: Afatinib, Dasatinib, Palbociclib, Everolimus, Olaparib

Sites

1 site in 1 country

  • Arthur J.E. Child Comprehensive Cancer CentreCalgary, Alberta, Canada