Study on Olutasidenib for Patients with IDH1 Mutation Positive Cancers

Inclusion Criteria

• Must be 18 years or older.
• Must be in good general health with a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have recovered from side effects of previous treatments to a mild level or baseline, except for certain conditions like infertility or hair loss.
• Must have a confirmed diagnosis of cancer with an IDH1 mutation, such as acute myeloid leukemia (AML), gastrointestinal cancers, or glioma.
• Must not have taken olutasidenib in the two weeks before starting the study.
• Must have good organ function, as shown by specific blood tests for liver and kidney function.
• Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use two forms of birth control during the study and for three months after.
• Men with partners who can become pregnant must agree to use effective birth control during the study and for three months after.
• Men must not donate sperm during the study and for three months after.

Exclusion Criteria

• Women who are pregnant or breastfeeding.
• Patients who smoke or have smoked within the last month.
• Patients who have consumed alcohol within 72 hours before starting the study.
• Patients planning to become pregnant or father a child during the study or within three months after.
• Patients with known allergies to the study drugs.
• Patients with HIV or active hepatitis B or C infections.
• Patients with serious infections requiring antibiotics within seven days before starting the study.
• Patients taking certain medications that affect liver enzymes within 14 days before starting the study.
• Patients with significant health issues that could affect the study or the way the body processes the study drug.
• Patients who have had cancer treatments or major surgery within four weeks before starting the study.
• Patients with a history of another cancer unless they have been disease-free for at least 12 months.
• Patients with serious heart conditions or prolonged QT interval on an ECG.
• Patients with severe heart failure.