NCT05432518 Pilot Trial for Treatment of Recurrent Glioblastoma
| NCT ID | NCT05432518 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2023-06-27 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. It will be aimed to gather preliminary information on the study intervention and the feasibility of conducting a full-scale trial.
Eligibility Criteria
Inclusion Criteria: 1. Study participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. 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. 3. Recurrence is amenable to resection. 4. Performance status: ECOG ≤2. 5. 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. 6. 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. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. 7. Able to undergo brain MRIs. 8. Females must not be breastfeeding, throughout the study period up to 180 days after the last dose of study intervention. 9. Male patients should agree to not donate sperm during the study for at least 6 months until discontinuation of study drug. Exclusion Criteria: 1. Patients with history of abnormal left ventricular ejection fraction (LVEF≤ 45%). 2. Pregnant, breast-feeding, unwilling/unable to comply with contraception requirements. 3. Patients unable to consent. 4. Abnormal (grade ≥2 CTCAE, version 5.0) laboratory values for hematology, renal, and liver function including: 1. Hemoglobin \<10, 2. Neutrophils \<1.5, 3. Platelets \<75, 4. ALT/AST \>3x ULN, 5. Bilirubin \>1.5 x ULN, 6. eGFR \<60 5. 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). 6. Patients with a history of ILD (interstitial lung disease) must be excluded. 7. Patients with severe hepatic impairment (Child Pugh C). 8. A significantly abnormal ECG (baseline QTcF interval \> 450 msec). 9. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. 10. Patients with known pre-existing pleural effusion. 11. Active hepatitis B or C infection and/or known history of HIV infection. 12. Has known psychiatric or substance abuse disorders that would interfere with compliance with the requirements of the trial. 13. Subject will not be available for protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge. 14. 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. 15. Patients who are hypersensitive to any ingredients in the formulation of the study drugs or their excipients. 16. Patients receiving active treatment for a different cancer. 17. If recent bacterial infection, patients need to have completed antibiotic course prior to commencing study drug. 18. If recent COVID-19 infection, patients must have recovered from it prior to commencing study drug. 19. 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.
Contact & Investigator
Paula de Robles
PRINCIPAL INVESTIGATOR
Arthur J.E. Child Comprehensive Cancer Centre
Frequently Asked Questions
Who can join the NCT05432518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05432518 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05432518 currently recruiting?
Yes, NCT05432518 is actively recruiting participants. Contact the research team at paula.derobles@albertahealthservices.ca for enrollment information.
Where is the NCT05432518 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05432518 clinical trial?
NCT05432518 is sponsored by AHS Cancer Control Alberta. The principal investigator is Paula de Robles at Arthur J.E. Child Comprehensive Cancer Centre. The trial plans to enroll 10 participants.
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