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GlioblastomaEarly Phase 1NCT05432518

Pilot Trial for Treatment of Recurrent Glioblastoma

A Early Phase 1 study testing Afatinib, Dasatinib and Palbociclib in people with Glioblastoma and Recurrent Disease, run by AHS Cancer Control Alberta at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Afatinib, Dasatinib and Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
27 Jun 2023to 1 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Adult participants, male and female, aged ≥18 who have a pathologically confirmed IDH-wild type glioblastoma, with first or second progression of the tumor, after initial treatment with radiation therapy and temozolomide.
  • Recurrence is amenable to resection.
  • Performance status: ECOG ≤2.
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
  • Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 180 days after the last dose of study intervention. Women/men of childbearing potential must have agreed to use two highly effective contraceptive methods. In addition to routine contraceptive methods such as condom use, oral contraceptive, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
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  • Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
  • Able to undergo brain MRIs.
  • Females must not be breastfeeding, throughout the study period up to 180 days after the last dose of study intervention.
  • Male patients should agree to not donate sperm during the study for at least 6 months until discontinuation of study drug.

Who cannot join

  • Patients with history of abnormal left ventricular ejection fraction (LVEF≤ 45%).
  • Pregnant, breast-feeding, unwilling/unable to comply with contraception requirements.
  • Patients unable to consent.
  • Abnormal (grade ≥2 CTCAE, version 5.0) laboratory values for hematology, renal, and liver function including:
  • Hemoglobin <10,
  • Neutrophils <1.5,
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  • Platelets <75,
  • ALT/AST >3x ULN,
  • Bilirubin >1.5 x ULN,
  • eGFR <60
  • Patients with significant or recent gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption or severe diarrhea of any etiology) must be excluded from the clinical trial (Afatanib is not recommended in this patient population).
  • Patients with a history of ILD (interstitial lung disease) must be excluded.
  • Patients with severe hepatic impairment (Child Pugh C).
  • A significantly abnormal ECG (baseline QTcF interval > 450 msec).
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • Patients with known pre-existing pleural effusion.
  • Active hepatitis B or C infection and/or known history of HIV infection.
  • Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
  • Subject will not be available for protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks from the date of signing the informed consent form.
  • Patients who are hypersensitive to any ingredients in the formulation of the study drugs or their excipients.
  • Patients receiving active treatment for a different cancer.
  • If recent bacterial infection, patients need to have completed antibiotic course prior to commencing study drug.
  • If recent COVID-19 infection, patients must have recovered from it prior to commencing study drug.
  • Patients on strong CYP3A/p-gp inducers (for example, carbamazepine and phenytoin).
  • N.B. Only patients receiving SOC neurosurgery in Alberta, Canada are eligible to participate in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

Other trials in Canada

About this study

Official title: Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma

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.

Being tested
Afatinib, Dasatinib, Palbociclib, Everolimus, Olaparib
Keywords
Glioblastoma, Recurrent Disease, Recurrent Glioblastoma, GBM
Medical subject headings
Glioblastoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfatinibDrug

    Also called Giotrif

    Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.

  • DasatinibDrug

    Also called Sprycel

    Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.

  • PalbociclibDrug

    Also called Ibrance

    Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.

  • EverolimusDrug

    Also called Teva-everolimus

    Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.

  • OlaparibDrug

    Also called Lynparza

    Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.

Study groups in NCT05432518
Study groupRoleWhat they receive
TreatmentExperimentalPatients 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
Receives: Drug: Afatinib; Drug: Dasatinib; Drug: Palbociclib; Drug: Everolimus; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of personalized GBM treatment based on molecular characterization of recurrent tumor

    Percentage of patients, interested in participating, consented and detected with target mutations and completed the treatment with one of the 5 study drugs

    Measured: From date of initial consent to participate to the end of follow up period (24 months)

Secondary outcomes (4)

  1. Overall survival (OS)

    OS is calculated as the period from the day of starting administration of the study drug to the day of death from any cause.

    Measured: From date of study drug administration until date of death from any cause (approximately 24 months)

  2. Progression free survival (PFS)

    PFS is calculated as the period from the day of starting administration of the study drug to the date that disease progression is confirmed by radiographic assessment and RANO criteria.

    Measured: From date of study drug administration until date of radiographic confirmed progression (approximately 2 years)

  3. Quality of Life (QoL) EORTC QLQ-C30

    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

    Measured: Baseline until the end of treatment

  4. Quality of Life (QoL) EORTC QLQ BN-20

    Quality of Life measures are recorded according to EORTC QLQ BN-20 module, which is validated for brain tumor patients and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment. EORTC QLQ BN-20 (BN-20): 4 scales comprised of multiple items and 7 single items. All items are rated on a 4-point Likert-type scale, 1=not at all' to 4=very much, and linearly transformed to a 0-100 scale, higher scores indicating more severe symptoms.

    The scores across all time points were averaged to obtain the mean.

    Measured: Baseline until the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start27 Jun 2023
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, pilot, umbrella trial
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432518
Sponsor's protocol ID
GBM-2022
Status last verified
Oct 2026
First submitted
21 Jun 2022
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Afatinib, Dasatinib and Palbociclib in people with Glioblastoma and Recurrent Disease, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432518.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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