Phase 2 Liver 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:

• For Phase 1: People who are at least 1 year old and no older than 21 years old at the time of joining the study.
• For Phase 2: People who are at least 1 year old and no older than 39 years old at the time of joining the study.
• For Phase 1: People who have a solid tumour that has come back or is no longer responding to treatment, not including tumours that started in the brain or spinal cord.
• For Phase 2: People diagnosed with fibrolamellar carcinoma (a rare type of liver cancer), confirmed by a specific genetic test showing a particular gene change (DNAJB1:PRKACA fusion), carried out by a certified laboratory.
• For Phase 1: People whose cancer can be measured or detected on scans or tests.
• For Phase 2: People whose cancer can be measured on scans or tests.
• For Phase 1: People whose cancer currently has no known cure or treatment proven to extend life with an acceptable quality of life.
• For Phase 2: People with fibrolamellar carcinoma that has come back or stopped responding to at least one previous systemic (whole-body) treatment.
• People who are well enough to carry out some daily activities, as measured by standard medical scoring tools appropriate for their age.
• People who have sufficiently recovered from side effects of any previous cancer treatments, and who have waited the required amount of time since their last treatment before joining (the exact waiting period depends on the type of treatment previously received — confirm with trial site).
• People who have not previously received treatments specifically targeting a protein called Bcl-xL (such as navitoclax or DT2216).
• People with solid tumours and no known cancer spread to the bone marrow who have an adequate white blood cell count (ANC at least 1000/µL).
• People with solid tumours and no known cancer spread to the bone marrow who have an adequate platelet count (at least 100,000/µL) without needing platelet transfusions in the 7 days before joining.
• People with cancer that has spread to the bone marrow may still be considered, provided blood count requirements are met, though some transfusions may be permitted (confirm with trial site).
• People whose kidney function meets the required level for their age and sex, based on a blood test, a 24-hour urine test, or a directly measured kidney filtration rate (confirm with trial site for specific values).
• People with solid tumours whose liver-related blood test results (bilirubin, ALT, AST, albumin) fall within the acceptable ranges set by the trial.
• People with solid tumours whose blood clotting measurement (INR) is 2.5 or below.
• People with a seizure condition may be considered if their seizures are well controlled on medication and have not increased in frequency in the 7 days before joining.
• People with nerve-related side effects from prior treatment that are mild (grade 2 or below), except that any level of reduced tendon reflex is acceptable.

Who may not be able to join:

• People who are pregnant or breastfeeding, or people of childbearing or reproductive potential who are not willing to use two effective methods of contraception for the duration of the study and for a specified period after the last dose of study medication.
• People currently taking corticosteroid medicines whose dose has not been stable or decreasing for at least 7 days before joining (or at least 14 days if the corticosteroids were used to manage immune-related side effects from prior treatment).
• People currently taking part in another clinical trial involving an experimental drug.
• People currently receiving any other anti-cancer treatment.
• People taking medicines to prevent graft-versus-host disease after a bone marrow transplant (such as cyclosporine or tacrolimus).
• People who have taken strong inhibitors or inducers of a liver enzyme called CYP3A4 within 14 days before joining (confirm with trial site for specific medications).
• People diagnosed with lymphoma.
• People with an active, uncontrolled infection.
• People experiencing diarrhea rated as grade 2 or worse at the time of joining.
• People who have previously received a solid organ transplant (such as a kidney, liver, or heart transplant).
• People whose cancer has spread to the brain or spinal cord (CNS metastases), whether causing symptoms or found incidentally.
• People with a heart rhythm abnormality at baseline where the QTc interval on an ECG is greater than 480 milliseconds.
• People who have had certain surgical procedures too recently before joining: a central line placed or a non-liver biopsy within 2 days, a liver biopsy within 7 days, or any other surgery within 14 days.
• People who, in the opinion of the trial doctor, may not be able to safely follow the monitoring requirements of the study.

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