Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05432518

Pilot Trial for Treatment of Recurrent Glioblastoma

Led by AHS Cancer Control Alberta · Updated on 2025-04-25

10

Participants Needed

1

Research Sites

231 weeks

Total Duration

On this page

Sponsors

A

AHS Cancer Control Alberta

Lead Sponsor

T

Tom Baker Cancer Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pilot Trial for Treatment of Recurrent Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent before starting any study procedures
  • Adults aged 18 or older with pathologically confirmed IDH-wild type glioblastoma
  • First or second tumor progression after radiation therapy and temozolomide treatment
  • Tumor recurrence can be surgically removed
  • Performance status of 0, 1, or 2 on the ECOG scale
  • Women of childbearing potential with negative pregnancy test at screening
  • Willingness to use two highly effective contraception methods during study and up to 180 days after last dose
  • Able to undergo brain MRI scans
  • Females must not be breastfeeding during study and up to 180 days after last dose
  • Male patients agree not to donate sperm during study and for 6 months after stopping study drug
Not Eligible

You will not qualify if you...

  • History of abnormal left ventricular ejection fraction (LVEF ≤ 45%)
  • Pregnant, breastfeeding, or unwilling/unable to follow contraception requirements
  • Unable to provide consent
  • Abnormal laboratory values (grade ≥2) including hemoglobin <10, neutrophils <1.5, platelets <75, ALT/AST >3x upper limit, bilirubin >1.5x upper limit, eGFR <60
  • Significant or recent gastrointestinal disorders with major diarrhea symptoms
  • History of interstitial lung disease
  • Severe liver impairment (Child Pugh C)
  • Abnormal ECG with QTcF interval >450 msec
  • Rare hereditary conditions affecting sugar metabolism
  • Known pre-existing pleural effusion
  • Active hepatitis B or C, or known HIV infection
  • Psychiatric or substance abuse disorders interfering with trial compliance
  • Unavailability for required study visits or procedures
  • Participation in another investigational study within 4 weeks prior to consent
  • Hypersensitivity to study drug ingredients
  • Receiving active treatment for another cancer
  • Recent bacterial infection without completed antibiotics
  • Recent COVID-19 infection without full recovery
  • Use of strong CYP3A/p-gp inducers (e.g., carbamazepine, phenytoin)
  • Only patients receiving standard neurosurgery in Alberta, Canada are eligible

AI-Screening

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Trial Site Locations

Total: 1 location

1

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

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Research Team

P

Paula de Robles, MD

CONTACT

M

Michelle Kan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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