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:

• Women aged 18 or older who have given written consent to take part before any study procedures begin.
• People diagnosed with a specific type of ovarian, fallopian tube, or primary peritoneal cancer (high-grade serous or endometrioid) that has come back or gotten worse after a first course of PARP inhibitor (PARPi) maintenance treatment.
• People who have received only one previous course of platinum-based chemotherapy, and that chemotherapy did not include a drug called bevacizumab.
• People who received a first maintenance therapy with a PARPi for at least 6 months; if that PARPi was olaparib, it must have been taken without serious side effects or the need for a permanent reduction in dose. People whose cancer came back after completing the full 24-month maintenance period are also considered eligible.
• People who have had a second cancer-reducing surgery that removed all visible tumour, or at least removed the areas where the cancer progressed during maintenance treatment.
• People whose BRCA1/2 gene status (mutated or normal) is documented, or who agree to have that genetic testing completed before joining the trial.
• People with a life expectancy of at least 16 weeks.
• People who are able to start the trial treatments between 3 and 8 weeks after their second surgery.
• People with a general health and activity level rated as ECOG 0 or 1, meaning fully active or restricted only in physically strenuous activity (confirm with trial site).
• People who are able to provide preserved tumour tissue samples from both their first and second surgeries for laboratory testing before the trial begins.
• People who are able to swallow and take oral (by mouth) medications.
• People whose blood, liver, and kidney function test results fall within acceptable ranges when measured within 28 days before starting treatment (specific thresholds apply — confirm with trial site).
• People who are post-menopausal, have been surgically sterilised, or have a negative pregnancy test within 28 days before starting treatment.
• People of childbearing potential and their partners who agree to use highly effective contraception during treatment and for at least one month after the last dose of olaparib (additional requirements apply for chemotherapy drugs — confirm with trial site).
• People who are willing and able to attend scheduled visits and follow all trial procedures.

Who may not be able to join:

• People considered at high medical risk due to a serious uncontrolled medical condition, uncontrolled infection, or non-cancer-related illness that could interfere with treatment or safety (examples include recent heart attack within 3 months, uncontrolled heart failure, uncontrolled high blood pressure, uncontrolled seizures, certain serious lung conditions, or unstable psychiatric illness).
• People who cannot swallow medication or who have digestive conditions likely to prevent the study drugs from being properly absorbed.
• People whose cancer and health situation makes them eligible for a treatment plan combining platinum-based chemotherapy with bevacizumab.
• People who have received systemic chemotherapy or radiotherapy (other than palliative treatment) within 3 weeks before starting the trial; palliative radiation must have been completed at least 7 days before starting, and any side effects must have resolved.
• People who have had major surgery within 2 weeks of starting the trial, or who have not yet recovered from a recent surgery.
• People who have previously had a bone marrow transplant or double umbilical cord blood transplant.
• People who are currently breastfeeding.
• People with brain metastases (cancer spread to the brain) that are causing symptoms and are not under control (a brain scan is required at the start; people on a stable dose of corticosteroids started at least 4 weeks before treatment may still be considered — confirm with trial site).
• People with another current or recent cancer, unless it was successfully treated with no sign of return for 5 or more years (certain exceptions apply, such as some treated skin cancers or early-stage cervical or endometrial cancers — confirm with trial site).
• People who received a whole blood transfusion in the 120 days before joining (transfusions of packed red blood cells or platelets are acceptable, as are transfusions that occurred during surgery).
• People who still have ongoing side effects from previous cancer treatment that are rated above a mild level (Grade 2 or higher), except for hair loss.
• People whose resting heart tracing (ECG) shows uncontrolled or potentially serious heart conditions, or people born with a condition called long QT syndrome.
• People currently taking certain medicines known to strongly or moderately affect how the body processes olaparib (specific drug examples include some antifungals, antibiotics, heart medications, and HIV treatments — a washout period of 2–5 weeks before starting olaparib may be required — confirm with trial site).
• People currently taking certain medicines known to reduce how well olaparib works in the body (examples include some anti-seizure drugs, certain antibiotics, and St John's Wort — a washout period of 3–5 weeks before starting olaparib may be required — confirm with trial site).
• People with a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or with test results suggesting these conditions.
• People with a weakened immune system, including those known to be HIV-positive.
• People with a known allergy to olaparib or any of its ingredients.
• People who, in the treating doctor's opinion, are not suitable for retreatment with platinum-based therapy according to European oncology guidelines (for example, those who had a serious allergic or adverse reaction to platinum drugs during first-line treatment).
• People with active hepatitis B or C infection (people with past resolved hepatitis B, or hepatitis C antibodies but no active virus detected by testing, may still be considered eligible — confirm with trial site).
• People who have taken part in another clinical trial using an experimental treatment within the last 3 months.

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