Phase 2 Ovarian Cancer Trial, Not Yet 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 take part voluntarily, sign a consent form, follow the treatment plan, and attend scheduled check-ups
• Women aged 18 or older (based on the date the consent form is signed)
• People who have been newly diagnosed — confirmed by laboratory testing of tissue — with high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; or with grade II or higher ovarian endometrioid adenocarcinoma (for mixed tumour types, the high-grade component must make up more than 50% of the tumour)
• People whose cancer has been staged as Stage III or Stage IV using the 2018 FIGO staging system
• People whose cancer has tested positive for HRD (a genetic marker related to how cancer cells repair DNA damage)
• People who have completed 6 to 9 cycles of platinum-based chemotherapy (or at least 4 cycles if there is a documented medical reason for not tolerating more), including at least 3 cycles of a drug called bevacizumab combined with the chemotherapy before joining the trial (specific minimum requirements apply for people who had interval surgery — confirm with trial site)
• People whose cancer showed no evidence of disease, or a complete or partial response, after their first round of chemotherapy — and who begin the study drug within 8 weeks of their last chemotherapy dose
• People with a general health and activity level rated 0 or 1 on the ECOG scale, meaning they are either fully active or have minor limitations in physically strenuous activity (confirm with trial site)
• People whose blood, liver, and kidney test results meet specific minimum levels set by the trial (no blood products or growth factor treatments in the 14 days before joining)
• Women who could become pregnant must have a negative pregnancy test within 72 hours before joining, agree to use an approved form of contraception during the study and for 6 months after the last dose, and must not be breastfeeding

Who may not be able to join:

• People who have had another cancer in the past 5 years that has not been treated, or who currently have another untreated cancer (exceptions include certain cured cancers such as thyroid cancer, skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence for more than 3 years after surgery)
• People with cancer that has spread to the brain or spinal cord lining and has not been treated (people who have received definitive treatment for brain metastases, with stable disease confirmed for at least one month and no ongoing steroid treatment, may be considered — confirm with trial site)
• People who have previously taken any PARP inhibitor medication, including olaparib, niraparib, rucaparib, pamiparib, or fluzoparib
• People who are unable to swallow tablets, or who have a digestive condition that may affect how the body absorbs the medication
• People who have had a bowel obstruction or a hole in the gastrointestinal tract in the past 3 months
• People who have fluid build-up from cancer in the abdomen or chest that requires draining, or who have had such drainage within the past 3 months
• People with significant heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack in the past year, certain heart rhythm problems requiring treatment, or an abnormal heart electrical reading (QTc interval above 470 ms)
• People with blood clotting problems shown in their test results, or who are currently taking blood-thinning medication (low-dose preventive blood thinners such as low-molecular-weight heparin or low-dose aspirin may be an exception — confirm with trial site)
• People who have had a significant bleeding event in the 3 months before joining, such as gastrointestinal bleeding or bleeding stomach ulcers
• People with a positive stool blood test that remains positive on repeat testing and is confirmed as a concern after clinical review
• People with active open wounds, unhealed fractures, or blood pressure that remains high despite treatment (above 140/90 mmHg)
• People who have had a bleeding event rated Grade 2 or above in the 4 weeks before joining
• People with an active infection or unexplained fever above 38.5°C during the screening period
• People with immune system conditions such as HIV, or active hepatitis B or C
• People whose side effects from previous cancer treatments have not yet recovered to a mild level (Grade 1 or below), or who finished previous cancer treatment less than 4 weeks before starting the study drug (or less than 5 half-lives for certain oral targeted therapies)
• People who have had a blood clot, stroke, or related event (including deep vein thrombosis, pulmonary embolism, or cerebrovascular events) in the 6 months before joining
• People with an inherited or acquired bleeding disorder, such as haemophilia or thrombocytopenia
• People who plan to receive other systemic cancer treatments during the study
• People with any other medical condition or situation that, in the opinion of the study doctor, could result in them not being able to safely complete the trial

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