Phase 1 Brain Cancer Trial, Recruiting

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:

• People who have been diagnosed with glioblastoma (a type of brain tumour) that has been confirmed by laboratory testing of tissue, and the tumour has come back for the first or second time.
• People who are taking steroid medication at a stable or reducing dose at the time of screening.
• People who have had a brain scan (MRI, both with and without contrast dye) completed within 5 days of starting the study treatment.
• People who have already completed standard treatment for glioblastoma — including surgery or biopsy and radiation therapy — and have recovered from its effects.
• People previously treated with certain types of targeted radiation (brachytherapy or stereotactic radiosurgery) who have had confirmation that their tumour is truly growing back, not just showing changes from the radiation itself.
• People with a life expectancy of more than three months.
• People with a Karnofsky Performance Status score of 70 or above — a medical measure of ability to carry out daily activities (confirm with trial site).
• People whose blood pressure is well controlled (within a specific healthy range) on a stable dose of medication.
• People with adequate bone marrow and organ function, confirmed by blood tests at screening.
• People — or their caregiver — who are able to store the study drug in a refrigerator, prepare and give daily injections under the skin at a set time, and keep a daily treatment diary.
• Women who could become pregnant must agree to pregnancy testing throughout the study and use medically accepted contraception during the study and for 2 months after the last dose of study drug.
• Men must agree to use medically accepted contraception and not donate sperm during the study and for 2 months after the last dose of study drug.

Who may not be able to join:

• People with a serious medical condition that is not well controlled, could hide side effects, could significantly affect how the body processes the drug, or could make participation in the study unsafe.
• People with a history of any other cancer (other than certain minor skin cancers), unless that cancer has been fully in remission and untreated for at least 3 months before the first dose of study drug.
• People who have received bevacizumab or any other experimental drug or treatment within 28 days before starting the study treatment.
• People who have previously been treated with the study drug (fb-PMT) or closely related drugs.
• People who are currently pregnant or breastfeeding.
• People with an active infection or another serious ongoing medical illness.
• People who have had any type of surgery within the past 28 days that has not fully healed.
• People with a wound, ulcer, or bone fracture that is serious or not healing.
• People with a known blood clotting or bleeding disorder, or a history of abnormal bleeding within 28 days before study treatment.
• People with a known inherited or diagnosed condition that increases the risk of blood clots (such as Protein S, Protein C, or antithrombin III deficiency, Factor V Leiden, Factor II mutation, high homocysteine levels, or antiphospholipid antibody syndrome). Note: testing for these conditions is not required unless there is a history suggesting a clotting problem.
• People who have evidence of new bleeding in the brain on a baseline MRI taken within 14 days before joining the study.
• People who have had a significant heart event — such as uncontrolled or symptomatic irregular heartbeat, heart failure, or a heart attack — within 6 months before screening.
• People with heart disease classified as New York Heart Association Class 3 or 4 (a medical measure of how much heart disease affects daily activity — confirm with trial site).
• People whose heart electrical measurement (QTc interval) is above a certain level at screening — above 450 milliseconds for men or above 470 milliseconds for women (confirm with trial site).
• People currently taking medications that are known to affect a specific heart electrical measurement (QT/QTc interval) or that may cause a dangerous heart rhythm called Torsades de Pointes.
• People taking certain medications known to affect how the liver processes drugs (specifically OATP1B1, OATP1B3, or BSEP inhibitors) within 14 days or five half-lives of those medications — whichever is longer — before starting the study drug (confirm with trial site).
• People who have had an abdominal fistula (an abnormal internal connection), a hole in the digestive tract, or an abdominal abscess within 6 months before joining the study.
• People who have had a significant blood vessel problem — such as a large aortic aneurysm requiring surgery, or a deep vein or arterial blood clot — within the past 6 months.
• People with a history of stroke, heart attack, a brief stroke-like episode (TIA), severe or unstable chest pain, peripheral vascular disease, or moderate-to-severe heart failure within the past 6 months.
• People with a history of a dangerous heart rhythm called Torsades de Pointes, or risk factors for it — such as heart failure, low potassium levels, or a family history of Long QT Syndrome.

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