Testing Afatinib with Dasatinib for glioblastoma
Official title: Pilot Trial for Treatment of Recurrent Glioblastoma
Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma
Interventions
Afatinib
Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.
Dasatinib
Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.
Palbociclib
Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.
Everolimus
Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.
Olaparib
Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.
Canadian Sites (1)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Eligibility Criteria
See who this study is looking for35 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Study participant has provided informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to initiation of any study specific activities/procedures.
- +Recurrence is amenable to resection.
- +Performance status: ECOG ≤2.
- +Able to undergo brain MRIs.
- +Male patients should agree to not donate sperm during the study for at least 6 months until discontinuation of study drug.
- +Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →. 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.
- +Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
- +Females must not be breastfeeding, throughout the study period up to 180 days after the last dose of study intervention.
- +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.
- +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 protocolProtocolThe detailed plan a study must follow.Read more →, he/she is responsible for beginning contraceptive measures.
Exclusion
- −Patients who are hypersensitive to any ingredients in the formulation of the study drugs or their excipients.
- −Active hepatitis B or C infection and/or known history of HIV infection.
- −Patients with history of abnormal left ventricular ejection fraction (LVEF≤ 45%).
- −Patients unable to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- −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,
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more → (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 (baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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.
- −Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial.
- −Subject will not be available for protocolProtocolThe detailed plan a study must follow.Read more →-required study visits or procedures, to the best of the subject's and investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 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).
- −Pregnant, breast-feeding, unwilling/unable to comply with contraception requirements.
- −N.B. Only patients receiving SOCStandard of careThe treatment normally given for a condition outside a study.Read more → neurosurgery in Alberta, Canada are eligible to participate in this trial.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Early Phase 1Early Phase 1A very small, very early study of how the body handles a treatment.Read more → — the earliest human testing, in a very small group, to observe how the body handles it.
What is being given or done in this study: Afatinib, Dasatinib, Palbociclib, Everolimus, and 1 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: From date of initial consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate to the end of follow upFollow-upContinued check-ins after the treatment part is finished.Read more → period (24 months).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Success rate of personalized GBM treatment based on molecular characterization of recurrent tumor — measured over From date of initial consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate to the end of follow upFollow-upContinued check-ins after the treatment part is finished.Read more → period (24 months).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05432518 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AfatinibDrug
Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DasatinibDrug
Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PalbociclibDrug
Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EverolimusDrug
Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About OlaparibDrug
Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From date of initial consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate to the end of follow upFollow-upContinued check-ins after the treatment part is finished.Read more → period (24 months).
The study as a whole is currently expected to finish around 2027-12-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Calgary, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.