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EGFR inhibitor

Personalized Treatment for Recurrent Glioblastoma

Phase < 1

Recruiting

Led By Paula de Robles

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants, male and female, aged ≥18 with pathologically confirmed IDH-wild type glioblastoma, first or second progression of the tumor, amenable to resection, and after initial treatment with radiation therapy and temozolomide.

Performance status: ECOG ≤2.

Must not have

Patients unable to consent.

Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial will study a personalized treatment for recurrent glioblastoma, and will aim to see if it is feasible to conduct a larger trial.

Who is the study for?

Adults over 18 with recurrent glioblastoma, not breastfeeding or pregnant, and willing to use contraception. Participants must have a performance status allowing daily activity (ECOG ≤2), be able to undergo brain MRIs, and have tumors suitable for resection. Excluded are those with certain heart, liver, kidney issues; gastrointestinal disorders; active infections; recent investigational drug use; other cancer treatments; or known psychiatric/substance abuse issues.

What is being tested?

The trial is testing a personalized treatment regimen based on the genetic profile of each patient's tumor using drugs like Everolimus, Olaparib, Dasatinib, Afatinib, Palbociclib. It's an early-stage study to see if it's feasible to conduct larger trials and gather initial data on these interventions in patients with recurrent glioblastoma.

What are the potential side effects?

Potential side effects may include fatigue, nausea, diarrhea (specifically from Afatanib), blood cell count changes leading to increased infection risk or bleeding problems. There could also be liver function changes and potential heart rhythm abnormalities due to abnormal ECG readings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult with a specific type of brain tumor that has come back after initial treatments.

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I can take care of myself but might not be able to do heavy physical work.

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I am a woman over 45 and have not had a period for 12 months due to menopause.

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I am not currently breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent by myself.

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I have a rare genetic issue with processing certain sugars.

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I have COVID-19 and haven't recovered before starting the study drug.

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I am currently taking medication that strongly affects how drugs are processed in my body.

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I have severe or recent stomach issues with diarrhea.

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I do not have active hepatitis B or C, nor HIV.

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I have a history of lung scarring or fibrosis.

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I have severe liver problems.

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I have fluid buildup in the lining of my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of study drug administration until date of radiographic confirmed progression (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of study drug administration until date of radiographic confirmed progression (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Overall survival (OS)

Progression free survival (PFS)

Quality of Life (QoL) EORTC QLQ BN-20

+1 more

Other study objectives

Correlation of genomic and expression profiling of tissue and organoid with the organoid's best drug response

Genomic and expression profiling

Organoid drug response

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046

26%

Febrile neutropenia

17%

Sepsis

Mucositis oral

Upper gastrointestinal hemorrhage

Hypotension

Hypertension

Intracranial hemorrhage

Enterocolitis

Small intestinal obstruction

Lower gastrointestinal hemorrhage

Fungemia

Peripheral motor neuropathy

Typhlitis

Oropharyngeal pain

Multi-organ failure

Abdominal pain

Hypoxia

Kidney infection

Edema limbs

Sinus bradycardia

Gastric hemorrhage

Myocardial infarction

Diarrhea

Fibrinogen decreased

Aspiration

Atrial fibrillation

Delirium

Endophthalmitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Chemotherapy)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment5 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Everolimus

FDA approved

Olaparib

FDA approved

Dasatinib

FDA approved

Afatinib

FDA approved