Phase 1 Kidney Cancer Trial, Recruiting

Written by an AI model from the 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 a blood cancer (such as acute myeloid leukemia, myelodysplastic syndrome, certain bone marrow disorders, chronic myelomonocytic leukemia, multiple myeloma, or non-Hodgkin's lymphoma) or a solid tumour (excluding brain tumours called gliomas), where testing has confirmed a specific genetic change called an IDH1 R132 mutation.
• People with moderate liver impairment, meaning their bilirubin level (a marker of liver function) is between 1.5 and 3 times the upper limit of normal (not due to a condition called Gilbert's disease), along with kidney function measured at a creatinine clearance of 60 mL/min or above.
• People with severe liver impairment, meaning their bilirubin level is more than 3 times the upper limit of normal, along with kidney function measured at a creatinine clearance of 60 mL/min or above.
• People with severe kidney impairment, meaning their creatinine clearance is between 15 and 29 mL/min, along with adequate liver function based on specific blood test results (confirm with trial site).
• People in a liver control group, meaning their liver function blood results are within or only mildly above normal range, and kidney function is at a creatinine clearance of 60 mL/min or above.
• People in a kidney control group, meaning their kidney function is at a creatinine clearance of 90 mL/min or above, and liver function is within acceptable limits (with allowances for people who have Gilbert's disease).
• People who have previously or are currently being treated with ivosidenib at the 500 mg once-daily dose, or at the 250 mg once-daily dose due to taking a specific type of interacting medication (a strong CYP3A4 inhibitor).
• People with a blood cancer who are also being treated with a medication called azacitidine alongside ivosidenib.
• Women who could become pregnant must agree to use two effective forms of contraception (one highly effective method plus a barrier method — hormonal contraception alone is not sufficient) from the time of giving consent, throughout the study, and for 90 days after the last dose.

Who may not be able to join:

• People who have had a stem cell transplant within the last 60 days, are currently on medications to suppress the immune system after a transplant, or have active graft-versus-host disease requiring treatment (though people managed with only a low-dose steroid may be considered with approval from the trial's medical monitor).
• People who have received systemic cancer treatment (other than azacitidine), an experimental treatment, or radiation therapy within the 14 days before the planned start date, or who have had surgery within 4 weeks before the planned start date, or who have not yet recovered from side effects of those treatments or surgeries.
• People with blood cancers (other than acute myeloid leukemia or myelodysplastic syndrome) or solid tumours for which other treatments with known clinical benefit are available.
• People who have taken a type of medication called calcineurin inhibitors within the 4 weeks before joining the trial.
• People who have had a significant heart condition in the 6 months before starting ivosidenib, including severe heart failure (NYHA Class III or IV), a heart attack, unstable angina, or a stroke.
• People taking medications known to affect the heart's electrical rhythm (QT interval prolongation) unless those medications can be safely switched or closely monitored during the trial (confirm with trial site).
• People planning to take certain medications that strongly interact with ivosidenib (specifically strong CYP3A4 inducers, certain CYP3A4 substrates with a narrow therapeutic window, or certain antifungal medications) during the trial period, unless an appropriate washout period has been completed beforehand.
• People with active inflammatory bowel disease, chronic diarrhoea, a history of stomach surgery or gastric banding, short bowel syndrome, delayed stomach emptying (gastroparesis), or other conditions that affect the ability to swallow or absorb oral medications.
• People with a family history of sudden death or a specific type of dangerous heart rhythm abnormality (polymorphic ventricular arrhythmia).

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