Phase 3 Ovarian 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 willing to join the study voluntarily, sign a consent form, and agree to attend follow-up visits
• Women aged 18 or older at the time of signing the consent form
• People who have been confirmed by tissue testing to have one of the following: high-grade serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or grade II or higher endometrioid adenocarcinoma of the ovary (for mixed tumour types, the relevant cancer component must make up more than 50% of the tumour)
• People whose cancer has been staged as Stage III or IV using the FIGO 2018 staging system
• People who have documented test results for HRD (a type of genetic test that looks at how cancer cells repair DNA damage)
• People who have completed platinum-based chemotherapy — at least 4 cycles if surgery was not possible, or at least 3 cycles after interval surgery
• People whose cancer showed no evidence of disease, a complete response, or a partial response to first-line platinum-based chemotherapy, with that response still present at the start of treatment, and where the study treatment begins within 8 weeks of the last chemotherapy dose
• People with a general health and activity level rated 0 or 1 on a standard scale (meaning fully active or able to carry out light activity, with minimal restrictions)
• People whose blood, liver, and kidney function test results are within acceptable ranges (without the help of blood transfusions or growth factor medications in the 14 days before joining)
• Women who could potentially become pregnant must have a negative pregnancy test within 72 hours before joining, agree to use approved contraception during treatment and for 6 months after the last dose, and must not be breastfeeding
• For people in the HRD-negative group only: a body mass index (BMI) of 18.5 or higher

Who may not be able to join:

• People who have had another cancer in the past 5 years that has not been treated or is still active (exceptions may include certain cured cancers such as thyroid cancer, basal cell skin cancer, cervical carcinoma in situ, or breast cancer with more than 3 years without recurrence after surgery)
• People with untreated cancer that has spread to the brain or spinal cord (those with stable, previously treated brain metastases that have been confirmed stable for at least 1 month and are no longer on high-dose steroids may still be considered — confirm with trial site)
• People who have previously been treated with a type of cancer drug called a PARP inhibitor (examples include olaparib, niraparib, rucaparib, pamiparib, or fluzoparib)
• People who are unable to swallow tablets, or who have a digestive condition that would prevent the study drug from being properly absorbed
• People who have had a bowel blockage or a hole in the digestive tract within the 3 months before joining
• People who have had fluid build-up from cancer in the abdomen or chest requiring drainage, or who have had such drainage within the 3 months before joining
• People with poorly controlled heart disease, including certain types of heart failure, unstable chest pain, a heart attack within the past year, significant irregular heartbeat requiring treatment, or an abnormal heart rhythm reading on an ECG
• People with blood clotting problems, a tendency to bleed, or who are currently using blood-thinning medications (low-dose preventive blood thinners may be permitted — confirm with trial site)
• People who have had a significant bleeding event in the 3 months before joining, such as gastrointestinal bleeding
• People with active ulcers, wounds that have not healed, or unhealed bone fractures
• People with high blood pressure that remains uncontrolled despite medication
• People who have had a moderate or severe bleeding event (Grade 2 or higher) in the 4 weeks before joining
• People with an active infection or an unexplained fever above 38.5°C during the screening period
• People with a weakened immune system, HIV, or active hepatitis B or C infection
• People who have received chemotherapy, radiation, hormonal therapy, or targeted cancer therapy within 4 weeks before starting the study treatment, or who still have significant side effects from previous cancer treatment
• People who have had a blood clot in an artery or vein (such as a stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism) within the 6 months before joining
• People with a hereditary or acquired bleeding disorder such as haemophilia or thrombocytopenia
• People who plan to use other systemic cancer treatments during the study
• People who, in the view of the trial doctor, have any condition that might make it unsafe or unsuitable for them to continue in the study
• For people in the HRD-negative group only: unintentional weight loss of 5% or more in the past 3–6 months, or signs of significant muscle and weight loss (cachexia)
• For people in the HRD-negative group only: a nutritional risk score of 3 or higher, or a need for nutritional support
• For people in the HRD-negative group only: diabetes that requires insulin or insulin-stimulating medications
• For people in the HRD-negative group only: active liver disease or liver problems
• For people in the HRD-negative group only: active kidney disease or kidney problems

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