Pilot Trial for Treatment of Recurrent Glioblastoma

Sponsor
AHS Cancer Control Alberta
Study ID
NCT05432518
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afatinib — DRUG
    Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.
  • Dasatinib — DRUG
    Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.
  • Palbociclib — DRUG
    Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.
  • Everolimus — DRUG
    Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.
  • Olaparib — DRUG
    Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.

Study Details

This will be a single-arm open-label prospective pilot feasibility trial recruiting 10 adult patients with recurrent glioblastoma who are assigned to receive the personalized study treatment based on the genetic profile of their recurrent GBM tumor resected at the time of surgery. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.

Key Dates

Start date
Jun 27, 2023
Status verified
Apr 2025
Primary completion
Jul 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    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

Primary Outcome Measure

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

Central Contacts

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