Phase 1 Kidney 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 are able to understand the study, follow its procedures, and give formal written consent before any study activities begin — including keeping to a specific blood-test schedule during the first treatment cycle.
• People who have a confirmed cancer diagnosis, which may include: a solid tumour that has spread or cannot be surgically removed and has no remaining standard treatment options; a blood cancer called AML (acute myeloid leukaemia) or MDS (myelodysplastic syndrome); or another blood cancer with no remaining standard treatment options.
• People with AML or MDS who have a confirmed diagnosis (excluding a specific subtype called M3 acute promyelocytic leukaemia), or who have newly diagnosed MDS or AML and are not suitable for standard intensive treatment (for example, due to older age, reduced physical functioning, serious lung problems, or elevated liver markers) — with specific minimum blood count levels required (confirm with trial site).
• People with blood cancers other than AML/MDS, or solid tumours, who meet higher minimum blood count requirements (confirm with trial site).
• People with a general physical functioning score between 0 and 3 on the ECOG scale, which ranges from fully active to capable of only limited self-care (confirm with trial site).
• People whose liver is functioning adequately, based on blood test results for bilirubin, AST, and ALT falling within acceptable ranges.
• People whose kidneys are either functioning normally or have severe kidney impairment that does not require dialysis — with stable kidney function confirmed between the screening visit and the day before treatment starts.
• People who have not had major surgery in the 30 days before starting the study treatment.
• People with a life expectancy of at least 3 months.
• Women who could become pregnant must not be pregnant or breastfeeding, must have a negative pregnancy test at screening, and must agree to use highly effective contraception for 6 months after finishing treatment.
• Male participants with female partners who could become pregnant must agree to use a condom and ensure their partner uses highly effective contraception, and must agree not to father a child for at least 3 months after finishing treatment.

Who may not be able to join:

• People who have received azacitidine or decitabine within the 4 weeks before screening, or who have had prior chemotherapy for AML (other than a specific medication used to manage high white blood cell counts).
• People who were hospitalised for more than 2 days in the 30 days before the first dose due to a serious infection-related condition such as fever with low white blood cell counts, pneumonia, or blood infection.
• People who have received another experimental treatment, chemotherapy, immunotherapy, or targeted therapy within 2 weeks (or longer, depending on the medication) before the first dose, or who still have significant ongoing side effects from a previous treatment.
• People currently receiving certain MDS treatments, including specific immune-modifying or blood-stimulating medications, unless those treatments were completed at least 1 week before the first study dose.
• People who have received a live (weakened) vaccine within 4 weeks before starting the study treatment, or who would need one before the follow-up visit; other vaccine types should also not be given within 7 days before starting treatment.
• People with serious uncontrolled medical conditions, active uncontrolled infections, or other health problems that may prevent completion of even one full treatment cycle.
• People with heart rhythm concerns, including a specific heart electrical measurement (QTc interval) that is too high at screening, a personal or family history of a dangerous heart rhythm condition, or who are taking other medications known to affect heart rhythm.
• People with unstable heart disease, severe heart failure, uncontrolled high blood pressure, or a history of significant episodes of dangerously low blood pressure.
• People with a significant mental health condition, or active alcohol or substance use issues, that in the treating doctor's opinion would make it difficult to safely follow the study requirements.
• People with AML or MDS whose disease is rapidly worsening and who are likely to need intensive chemotherapy within the next 3 months.
• People with life-threatening illness, severe organ dysfunction (such as uncontrolled heart failure or serious lung disease), or other conditions that could affect safety or interfere with how the study medication is absorbed or processed by the body.
• People with untreated cancer that has spread to the brain or spinal cord (those with treated and stable brain metastases for at least 4 weeks before screening may still be considered).
• People living with HIV.
• People with active hepatitis B or hepatitis C infection.
• People with a history of alcohol abuse or drug addiction, including cannabis.
• People whose average alcohol intake exceeds 24 units per week (for men) or 17 units per week (for women), where one unit equals approximately 250 mL of beer, 75 mL of wine, or 25 mL of spirits.
• People who have donated or lost more than 500 mL of blood in the 60 days before the first study dose.
• People with a known allergy or sensitivity to decitabine, cedazuridine, or any ingredient in the study medication.

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