Phase 2 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 with a newly diagnosed cancer of the ovary, fallopian tube, or peritoneum (the lining of the abdomen).
• People whose cancer type has been confirmed by a tissue sample as high-grade serous, high-grade endometrioid (grade 2 or 3), or another non-mucinous, non-clear cell epithelial ovarian cancer — with the last type requiring a specific inherited gene fault (BRCA 1 or 2 mutation).
• People whose cancer is at an advanced stage, specifically FIGO stage IIIA to IIIC (as classified in 2018).
• People who have already had complete surgery to remove all visible cancer (no remaining disease visible to the surgeon), with the surgery quality confirmed through a formal review process.
• People who are in good general health, rated 0 or 1 on a standard medical fitness scale (meaning fully active or able to carry out light activities).
• People who have already received one cycle of a standard chemotherapy combination (carboplatin and paclitaxel).
• People who started that first chemotherapy cycle no later than 6 weeks after their surgery.
• People who had a CT scan of the chest, abdomen, and pelvis between surgery and the first chemotherapy cycle, showing no remaining signs of disease.
• People whose treating doctor considers them suitable for standard platinum and taxane chemotherapy.
• People whose treating doctor considers them suitable to receive a medicine called bevacizumab alongside chemotherapy and continuing as ongoing treatment, starting at the second chemotherapy cycle.
• People whose blood test results before the first chemotherapy cycle show that the blood, liver, and kidney are functioning within acceptable ranges (confirm specific values with trial site).
• People whose urine protein levels are below a certain threshold (a urine test showing less than 2+ protein, or if 2+ or higher, a 24-hour urine collection showing less than 1g of protein).
• People with normal blood pressure, or whose blood pressure is well managed with treatment (no higher than 140/90 mmHg).
• People who can provide a stored tumour tissue sample from their primary cancer for genetic testing.
• In certain countries, people who are affiliated with or covered by a social security system (confirm with trial site which countries this applies to).

Who may not be able to join:

• People whose ovarian, fallopian tube, or peritoneal cancer is of the clear cell, carcinosarcoma, or non-epithelial type (such as germ cell tumours).
• People whose ovarian tumour is classified as low malignant potential (borderline tumour) or mucinous carcinoma.
• People who have been diagnosed with, or treated for, another type of cancer within the past 3 years — with some exceptions including certain skin cancers, cervical cancer in situ that has been fully treated, early-stage low-risk womb cancer, or a history of triple-negative breast cancer that was fully treated more than 3 years ago with no signs of return.
• People with a simultaneous high-grade serous or clear cell adenocarcinoma or carcinosarcoma of the womb lining.
• People with a history of certain blood or bone marrow conditions (myelodysplastic syndrome or acute myeloid leukaemia).
• People who have had radiotherapy within 6 weeks before starting the study treatment.
• People who have previously had a bone marrow transplant from a donor.
• People who have previously been treated with a type of medicine called a PARP inhibitor.
• People receiving other chemotherapy, cancer-fighting hormonal therapy, or radiotherapy at the same time as the trial treatment (with a specific exception for a surgical chemotherapy procedure called HIPEC with cisplatin; hormonal replacement therapy and steroid anti-nausea medicines are permitted).
• People who are regularly taking high-dose aspirin (more than 325 mg per day) within 10 days before joining the trial.
• People with a history of a severe hypertensive crisis (grade 4) or a condition called hypertensive encephalopathy.
• People with significant active heart or blood vessel disease, including a heart attack or unstable chest pain within the past 6 months, moderate-to-severe heart failure, poorly controlled heart rhythm problems, or severe problems with blood flow to the limbs.
• People who have previously had a stroke, mini-stroke (TIA), bleeding around the brain, or a condition called posterior reversible encephalopathy syndrome (PRES).
• People with a history or signs of abnormal bleeding disorders.
• People with evidence of significant problems with blood clotting.
• People with a history of, or suspected, cancer spread to the brain or pressure on the spinal cord.
• People with a history of or signs of uncontrolled nervous system disease (such as uncontrolled seizures).
• People who experienced a significant injury in the 4 weeks before joining the trial.
• People with a wound that is not healing, an active ulcer, or a bone fracture (people with certain healing wounds may still be considered — confirm with trial site).
• People with a history of a bowel hole (perforation), a fistula related to a specific type of anti-cancer drug (VEGF therapy), or active bowel bleeding within 6 months before the first study treatment.
• People with a current bowel blockage related to their underlying disease.
• People with unexplained free air in the abdomen.
• People with any other serious medical condition, test result, or physical finding that could make it unsafe to take part in the trial.
• People who are pregnant or breastfeeding.
• People already taking part in another clinical trial involving an experimental medicine (participation in a surgical trial including a HIPEC procedure is allowed).
• People who are unable to swallow tablets or capsules, or who have digestive conditions that would prevent the study medicine from being absorbed properly.
• People with a known allergy or serious sensitivity to paclitaxel, carboplatin, niraparib, bevacizumab, or any of their ingredients.
• People with a weakened immune system, known active hepatitis B or C, or a known positive HIV status.
• People with a serious uncontrolled medical condition, active uncontrolled infection, or a psychiatric condition that would prevent them from giving informed consent.

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