NCT03359850

Who might be able to join this trial:

• You are 18 years of age or older.
• You have been diagnosed with an advanced solid tumour (a type of cancer) that has not responded to standard treatments, is unlikely to benefit from standard treatments, or you have chosen not to have standard treatment.
• You are generally well enough to carry out light activity and care for yourself (a doctor's assessment called ECOG performance status 0 or 1).
• You are able to swallow and digest tablets or capsules taken by mouth.
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 3 days before starting the study drug and agree to avoid pregnancy during the trial and for 120 days after the last dose.
• If you are a man, you agree to use an effective method of contraception from your first dose until 120 days after your last dose.
• You are able to understand the study and are willing to give written consent to take part.

If you have normal liver function (Group 1), you must also:

• Have no history of liver problems.
• Have liver blood test results within the normal range.
• Have adequate blood counts and kidney function as measured by specific blood tests (confirm with trial site).

If you have moderate liver problems (Group 2), you must also:

• Have stable, moderate liver impairment that has been present for at least 2 weeks before starting the study (confirm with trial site).
• Have blood counts and kidney function that meet specific levels, which are slightly lower than those required for Group 1 (confirm with trial site).
• Have liver disease that your doctor considers to be stable.

Who may not be able to join:

• You have had radiation therapy covering more than 20% of your bone marrow within 1 week before starting the study drug.
• You are starting chemotherapy within 3 weeks of taking the study drug.
• You have a known allergy or sensitivity to niraparib or any of its ingredients.
• You have received growth factor injections (used to boost white blood cells) within 2 weeks before your first dose.
• You are still experiencing significant side effects (Grade 2 or higher) from previous chemotherapy, except for nerve damage, hair loss, or tiredness.
• You have brain or spinal fluid metastases (cancer that has spread to the brain or surrounding fluid) that are causing symptoms and are not under control.
• You have had major surgery within 3 weeks before starting the study, or have not fully recovered from major surgery.
• You have a serious uncontrolled medical condition (other than liver impairment) or an active uncontrolled infection.
• You have received a blood transfusion (platelets or red blood cells) within 3 weeks before taking the study drug.
• You are pregnant, breastfeeding, or planning to have children during the study or within 3 months of your last dose.
• You have a history of a blood or bone marrow condition called MDS or AML.
• You are currently taking, or cannot stop taking, certain specific medications that may interfere with how the study drug is processed in your body — including some medications for nausea, depression, sleep, muscle spasms, or breathing (confirm with trial site for the full list).
• You cannot avoid eating grapefruit or drinking grapefruit juice for 4 days before your first dose until your last study-related blood draw.
• You are taking, or cannot stop taking, certain medications that affect how your body absorbs or processes drugs — including some heart, antibiotic, antifungal, or immune-suppressing medications (confirm with trial site for the full list).
• You are taking antacids, proton pump inhibitors (e.g., omeprazole), or heartburn medications within 48 hours before or 6 hours after taking the study drug.
• You have a condition affecting your stomach or digestive tract, or have had surgery on your digestive system, that could affect how your body absorbs the study drug.

If you have moderate liver problems (Group 2), you also may not be able to join if:

• You have a condition causing confusion due to liver failure (hepatic encephalopathy), severe high blood pressure in the liver, or abnormal blood vessel connections in the liver.
• Your liver function is unstable or getting worse quickly.
• Your liver disease was caused by a drug reaction or an infection.
• Your liver problems