Phase 2 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 are willing and able to sign a written consent form before any study procedures begin.
• People aged 18 or older.
• People who have been diagnosed with kidney cancer (renal cell carcinoma), confirmed by a tissue sample — both common and less common types are allowed.
• People whose kidney cancer has spread to other parts of the body (Stage IV).
• People who have a specific genetic mutation in one of the following genes — BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L — confirmed by an approved clinical genetic test using tissue, saliva, or blood.
• People who have already received at least one prior treatment targeting blood vessel growth (anti-angiogenic) or a type of cancer immunotherapy (immune checkpoint inhibitor).
• People who have had any number of previous cancer treatments, including immunotherapy, targeted therapy, or clinical trials.
• People who have at least one area of cancer that can be measured on a scan, according to standard criteria (RECIST 1.1).
• People whose blood test results, taken within 28 days before starting treatment, show that the heart, liver, kidneys, and bone marrow are working within acceptable ranges — including healthy enough red blood cell, white blood cell, and platelet counts, as well as liver and kidney function (confirm specific values with the trial site).
• People whose kidney function meets a minimum threshold, measured by a standard formula or urine test (confirm with trial site).
• People who are reasonably active and able to care for themselves, with a performance status score of 0 or 1 on the ECOG scale (confirm with trial site).
• People who are expected to live for at least 16 weeks.
• Women who are past menopause or who are confirmed not to be pregnant, with a negative pregnancy test taken within 28 days before starting treatment and again confirmed on the first day of treatment.
• Male participants who agree to use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a pregnant woman or a woman who could become pregnant; female partners of male participants who could become pregnant should also use a highly effective form of contraception.

Who may not be able to join:

• People who have had another type of cancer in the last 5 years, unless it was successfully treated and there is no sign of it returning — some exceptions apply for certain low-risk or early-stage cancers (confirm with trial site).
• People with brain metastases (cancer spread to the brain) that are causing symptoms and are not well controlled — people with stable, treated brain metastases may still be considered (confirm with trial site).
• People with spinal cord compression, unless it has been definitively treated and the condition has been stable for at least 28 days.
• People who have previously had a bone marrow transplant or a double umbilical cord blood transplant.
• People who, in the opinion of the treating doctor, are unlikely to follow the study procedures and requirements.
• Women who are currently breastfeeding.
• People taking certain medications that are not allowed in this trial, within the past 2 weeks.
• People who are involved in planning or running this study.
• People who have taken part in another clinical trial involving an investigational treatment in the last 2 weeks.
• People who have received chemotherapy or radiation therapy (other than for pain relief) within 3 weeks before starting this trial.
• People who have previously been treated with a type of drug called a PARP inhibitor, including olaparib (the drug being studied in this trial).
• People with a specific heart rhythm abnormality on an ECG (QTc greater than 500 ms), uncontrolled heart conditions, or a personal or family history of a condition called long QT syndrome.
• People currently taking certain medications that strongly or moderately affect how the body processes the study drug — these include some antifungals, antibiotics, and HIV medications, among others (confirm specific medications with trial site).
• People currently taking certain medications that speed up the breakdown of the study drug in the body, such as some epilepsy medications, antibiotics, or St John's Wort (confirm specific medications with trial site).
• People who still have significant side effects (above a moderate level) from previous cancer treatment, not including hair loss.
• People who have or show signs of a blood or bone marrow disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People who have had major surgery within 2 weeks before starting the trial, or who have not yet recovered from surgery.
• People with serious, uncontrolled medical conditions or active infections — examples include uncontrolled heart rhythm problems, a heart attack within the past 3 months, uncontrolled seizures, severe lung disease, or a psychiatric condition that prevents someone from giving informed consent.
• People who are unable to swallow tablets or capsules, or who have gut or digestive conditions that may prevent the study drug from being properly absorbed.
• People with a weakened immune system, including those who are known to be HIV positive.
• People who are known to be allergic to olaparib or any of its ingredients.
• People with active hepatitis B or hepatitis C infection.
• People who have received a red blood cell or platelet transfusion within the 28 days before joining the trial.

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