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 have signed a consent form showing they understand and agree to take part in the trial before any trial procedures begin.
• Women aged 18 or older who have been diagnosed through a tissue biopsy with a specific type of advanced ovarian, peritoneal, or fallopian tube cancer (high grade, non-mucinous, non-clear cell) that has reached an advanced stage (FIGO stage IIIB through IV).
• People who have already had surgery to remove as much of the cancer as possible, or who are planning to have chemotherapy followed by that type of surgery.
• People who are able to provide a stored tumour tissue sample (a type called formalin-fixed, paraffin-embedded) so that a central laboratory can test for a gene change called BRCA before the trial begins.
• People who are able to start the trial's systemic (whole-body) treatment within 8 weeks of their cancer-removal surgery.
• People who are generally well enough to carry out everyday activities, with only mild limitations at most (as measured by a standard medical fitness scale called ECOG 0–1).
• People whose life expectancy is estimated to be more than 3 months.
• People whose blood test results show the bone marrow is producing enough blood cells — including white blood cells, platelets, and red blood cells — within the required timeframe before treatment starts.
• People whose blood clotting tests are within acceptable ranges, including those who are on a stable dose of blood-thinning medication (confirm with trial site).
• People whose liver and kidney function blood tests are within acceptable ranges before treatment starts.
• People who have normal blood pressure, or whose blood pressure is well controlled and measures no higher than 140/90 mmHg when checked at a clinic within the required timeframe.
• Women who could potentially become pregnant must have a negative pregnancy test within 7 days before the first treatment day.
• Women who could potentially become pregnant must agree to use a highly effective form of contraception (with a failure rate of less than 1% per year) — or remain completely abstinent from sex with male partners — during treatment and for at least 6 months after the last dose of medication. Some methods such as periodic abstinence or withdrawal are not accepted (confirm with trial site).
• People who are willing and able to attend all scheduled visits, follow treatment plans, complete lab tests, and fill in patient questionnaires throughout the trial.

Who may not be able to join:

• People whose ovarian tumour did not start in the epithelial (lining) tissue of the ovary.
• People with low-grade or borderline ovarian tumours.
• People who are planned to receive chemotherapy delivered directly into the abdomen (intraperitoneal chemotherapy).
• People who have had another cancer in the past 5 years, unless it was a type with very low risk of spreading or causing death and was treated with the expectation of a cure (for example, certain skin cancers, early-stage cervical changes, or early-stage breast duct changes — confirm with trial site).
• People who have already received any systemic (whole-body) treatment for ovarian cancer.
• People who have previously been treated with a type of drug called a PARP inhibitor.
• People who are receiving other chemotherapy, cancer treatments, anti-cancer hormone therapies, or radiotherapy at the same time as the trial treatment (hormone replacement therapy is permitted).
• People who have already been enrolled in this trial before.
• People who have had major surgery within 1 week before starting the trial treatment, or who have not fully recovered from major surgery.
• People with a history of, or suspected, cancer spread to the brain or spinal cord.
• People who have had a serious injury within 4 weeks before their first possible dose of the study drug bevacizumab.
• People who have had a stroke, mini-stroke (TIA), or bleeding around the brain within 6 months before treatment starts.
• People who have had a blood clotting or bleeding disorder within 3 months before treatment starts.
• People with a history of, or signs of, a disease affecting the central nervous system (brain and spinal cord) that is not well controlled — for example, uncontrolled seizures.
• People who are pregnant or currently breastfeeding.
• People who have taken part in another clinical drug trial within 4 weeks (or within 5 times the removal period of that drug, whichever is longer) before the trial starts, or who are taking part in another drug trial at the same time.
• People who have a known allergy or serious sensitivity to any of the trial's study drugs (bevacizumab, niraparib, paclitaxel, or carboplatin) or their ingredients.
• People with a wound that is not healing, an active ulcer, or a bone fracture that has not healed (some exceptions may apply — confirm with trial site).
• People with significant heart or blood vessel problems, including a heart attack or unstable chest pain within the past 6 months, moderate-to-severe heart failure, poorly controlled irregular heartbeat, significant disease of the peripheral blood vessels, or a large aortic aneurysm requiring surgery.
• People who already have nerve damage affecting sensation or movement at a moderate level or worse (Grade 2 or above).
• People with a history of, or current, nephrotic syndrome (a kidney condition causing too much protein to be lost in urine).
• People with an ongoing bowel blockage related to their cancer (some people with a past history of bowel blockage who have fully recovered may be considered — confirm with trial site).
• People who have had an abnormal connection (fistula) in the abdomen or between the food pipe and windpipe, a hole in the gut, active gut bleeding, or a surgical join in the gut that has broken down, within 6 months before treatment starts.
• People who are unable to swallow tablets or capsules, or who have a digestive condition that would prevent the study drug niraparib from being properly absorbed.
• People with any other serious uncontrolled illness, abnormal test result, or condition that a doctor considers would make taking part in the trial unsafe.
• People who have a history of, or currently have, a bone marrow condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML).
• People who have previously had a bone marrow transplant from a donor, or an organ transplant.
• People currently taking aspirin at a dose greater than 325 mg per day within 10 days before treatment starts, or people taking certain other blood-thinning medications that reduce platelet function (such as clopidogrel or similar drugs — confirm with trial site).
• People with a serious uncontrolled medical or psychiatric condition that would prevent them from giving informed consent or safely taking part.
• People with known active hepatitis B or hepatitis C infection.
• People with a history of a brain condition called Posterior Reversible Encephalopathy Syndrome (PRES).
• People with chronic inflammatory bowel disease who are currently receiving treatment to control it.

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