Phase 2 Haemophilia Trial, Completed

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Adults (18 years and older):

• People who have been diagnosed with a type of brain tumour called glioblastoma (confirmed by laboratory testing of tumour tissue), where the tumour has clearly come back or grown again.
• People whose tumour came back at least 3 months after finishing radiation therapy, or whose tumour has grown in an area outside where radiation was given, or whose tumour recurrence has been confirmed by surgery or biopsy.
• People who have tumour tissue samples (preserved in a specific way called formalin-fixed paraffin embedded) available for a central laboratory to test for a specific genetic change called EGFR amplification.
• People whose tumour has been confirmed by a central laboratory to have EGFR amplification (a specific change in a gene that affects tumour growth).
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (WHO Performance Status 0–2).
• People who have had no more than one course of chemotherapy (a chemotherapy regimen combining concurrent and follow-up Temozolomide counts as one course), completed at least 4 weeks before joining the trial.
• People who have had a brain scan (MRI) within 2 weeks before joining the trial, and, if they had recent surgery, also within 48 hours after that surgery.
• People who have fully recovered from surgery, with surgery completed at least 2 weeks before joining the trial.
• People whose kidneys are functioning at an adequate level, based on a standard calculation (creatinine clearance of at least 30 mL/min).
• People whose liver is functioning at an adequate level, based on standard blood test results (bilirubin below 1.5 times the upper limit of normal, and certain liver enzymes below 2.5 times the upper limit of normal).
• People without any personal, family, social, or location-related circumstances that might make it difficult to follow the trial schedule (confirm with trial site).

Children and young people (under 18 years old — separate part of the trial):

• Young people with a confirmed high-grade brain tumour (including certain grade III or grade IV tumours, or a specific type called diffuse intrinsic pontine glioma).
• Young people whose tumour has come back or is growing, or — if newly diagnosed — who have finished any planned radiation therapy at least 4 weeks before the first dose of the trial treatment.
• Young people whose tumour has been tested and confirmed to have EGFR amplification (a specific gene change).
• Young people who have tumour tissue available for a central laboratory to confirm EGFR amplification.
• Young people who have sufficiently recovered from previous treatment, and where the treating doctor considers that the potential benefits of the trial treatment outweigh the risks.
• Young people whose kidneys are functioning at an adequate level, based on standard calculations appropriate for their age.
• Young people whose liver is functioning at an adequate level, based on standard blood test results; young people with a documented condition called Gilbert's syndrome may still be considered if their bilirubin level is below 3 times the upper limit of normal (confirm with trial site).

Who may not be able to join:

Adults (18 years and older):

• People who have previously been treated with a chemotherapy drug called nitrosoureas.
• People who have previously been treated with a drug called bevacizumab.
• People who have previously received any treatment that targets the EGFR protein, including treatments targeting a specific form called EGFRvIII.
• People who previously had to stop taking Temozolomide chemotherapy because of harmful side effects.
• People who received a very high dose of radiation to the brain (over 65 Gy), or certain types of specialised radiation treatment, unless the return of the tumour has been confirmed by surgery or biopsy.
• People who have had another type of cancer, unless it was treated with the intention of curing it more than 5 years ago, or unless it was a limited and well-controlled skin cancer or a very early-stage cervical condition.
• People who are women of childbearing potential and do not have a negative pregnancy test result (from blood or urine) taken within 72 hours before joining the trial.
• People who have a history of wheat allergy or coeliac disease.
• People who are taking a type of anti-seizure medication known as enzyme-inducing antiepileptic drugs (EIAEDs); those who were previously on these medications must have fully switched to a different type at least 2 weeks before joining the trial.

Children and young people (under 18 years — separate part of the trial):

• Young people with a returning tumour who previously received a very high dose of radiation to the brain (over 65 Gy) or certain specialised radiation treatments, unless the tumour's return has been confirmed by surgery or biopsy.
• Young people who are currently receiving, or have recently received (within 4 weeks or 5 half-lives of the drug, whichever is shorter), another experimental treatment.
• Young people who are female and of childbearing potential and do not have a negative pregnancy test result (from blood or urine) taken within 72 hours before joining the trial.
• Young people with known ongoing or chronic liver disease or cirrhosis.

Important: Always verify eligibility with the trial site directly before applying.