Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person must give written consent to take part before any trial-related procedures begin.
• The person must be a woman aged 18 or older.
• The person must have been diagnosed with Stage III or Stage IV high-grade ovarian cancer (all tissue types except mucinous).
• The person must have had surgery that removed all visible signs of the tumour, confirmed by a CT scan taken after the operation.
• A tumour tissue sample (preserved in a specific way called formalin-fixed, paraffin-embedded) must be available for genetic testing, and the results must show a specific genetic profile linked to DNA repair problems (called HRD-positive), based on set criteria (confirm with trial site).
• The person must be in reasonably good general health, able to carry out normal daily activities with little or no limitation (rated 0 or 1 on a standard medical scale).
• The person must be able to swallow and take oral (by mouth) medications.
• People with another cancer at the same time may still be considered, as long as the other cancer does not affect the outlook for the ovarian cancer — the trial team must be consulted before enrolment.
• Blood and organ function must meet specific healthy levels, including adequate red blood cells, white blood cells, platelets, liver function markers, and kidney function (confirm specific values with trial site).
• The person must either be post-menopausal, permanently unable to become pregnant (for example, due to prior removal of the uterus or ovaries), or must have a negative pregnancy test within 3 days before starting treatment.
• Women who could become pregnant must use highly effective contraception during the trial and for at least 6 months after the last dose of chemotherapy or the last dose of niraparib, whichever comes later.

Who may not be able to join:

• People whose cancer originated from non-epithelial cells (such as germ cell tumours), or who have low-risk borderline tumours, or mucinous ovarian cancer.
• People with low-grade ovarian, fallopian tube, or peritoneal cancer.
• People with a known allergy to any of the study drugs or their ingredients.
• People with a known allergy to platinum-based drugs other than carboplatin.
• People who have previously had an organ or bone marrow transplant.
• People who had a second surgery to reduce the tumour (called interval debulking) rather than complete removal during the first surgery.
• People who have already received any anti-cancer treatment for ovarian cancer other than the initial surgery.
• People who are receiving or plan to receive other chemotherapy, anti-cancer treatments, cancer-related hormonal therapy, or radiotherapy at the same time as the trial treatment.
• People who have previously been treated with a type of drug called a PARP inhibitor, or who have taken part in a trial where a PARP inhibitor was used.
• People for whom a drug called bevacizumab is planned as part of their first-line chemotherapy or as ongoing maintenance treatment.
• People with significant heart or blood vessel problems, including a heart attack, stroke, or unstable chest pain within the past 6 months; severe uncontrolled heart rhythm problems; moderate to severe heart failure; uncontrolled high blood pressure; a history of hypertensive crisis or related brain conditions; artery bypass surgery within the past 6 months; or a blood clot within the past month.
• People with a history of cancer that has spread to the brain or spinal cord.
• People with a known history of a blood disorder called MDS, or genetic test results suggesting a risk of MDS or a related blood cancer called AML.
• People with a bowel blockage at the time of joining the trial.
• People with digestive system problems that could prevent the study medication from being properly absorbed.
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not willing to use highly effective contraception as required by the trial.
• People who have recently taken part in another clinical trial using an experimental treatment, unless enough time has passed since that treatment (confirm with trial site).
• People with a known history of HIV infection or AIDS.
• People with known active Hepatitis B or Hepatitis C infection.
• People with a currently active COVID-19 infection (confirmed by antigen test).
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or BCG) within 30 days before starting treatment, or during treatment, or within 28 days after the last dose of trial treatment.
• People for whom the study drugs are otherwise contraindicated according to the official prescribing information.
• People who may be in a dependent relationship with the trial sponsor, research organisation, trial site, or investigator.
• In Germany: People who are imprisoned or have been involuntarily institutionalised by a court or government authority.

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