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New treatment option for Glioblastoma
Official title Pilot Trial for Treatment of Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT05432518
What this study is testing
What is Afatinib?
Afatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma.
Also referred to as Giotrif.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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,
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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,
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.