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:

• People who have signed a written consent form before any study procedures begin.
• Women aged 18 or older.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (confirm with trial site for exact rating scale used).
• People with a life expectancy of at least 16 weeks.
• People with a confirmed diagnosis of high-grade serous or endometrioid ovarian cancer whose disease showed limited progression during or after their first maintenance therapy with a PARP inhibitor (a type of cancer drug).
• People whose cancer has progressed in only 1 to 5 specific spots in the body, as defined by international radiology guidelines.
• People who have had a second surgery to remove tumours, with a central review confirming that no visible tumour was left behind after the operation.
• People who have brain metastases that are not causing symptoms and have already been treated, provided brain surgery was completed at least 28 days before the study treatment starts, no radiation therapy to the brain is needed, and no steroids or anti-seizure medications have been taken for at least 7 days before the first study dose.
• People whose BRCA1/2 gene mutation status and/or homologous recombination (DNA repair pathway) status has been documented and tested before the first study treatment day.
• People who previously received a PARP inhibitor alone, or together with bevacizumab, as maintenance treatment.
• People whose previous PARP inhibitor treatment lasted at least 12 months before limited disease progression occurred, or whose cancer progressed after completing that treatment, with progression confirmed by CT and/or PET-CT scan.
• If the previous PARP inhibitor treatment was niraparib specifically, people who did not stop that treatment due to serious side effects.
• People willing to provide tumour tissue samples from their first and second surgeries (if available), as well as blood samples at the start of the study, every 12 weeks, and at the end of treatment.
• People who are able to swallow oral (tablet or capsule) medications.
• People who are able to start study treatment between 3 and 8 weeks after their surgery, once recovered.
• Women who could become pregnant must agree to use contraception methods as specified by the study site, must not donate eggs during the study period, and must have a negative pregnancy test within 72 hours before starting treatment.
• People whose bone marrow, liver, and kidney are functioning within the blood test levels required by the study (confirm specific values with trial site).
• People who are able to attend all required treatment and follow-up visits.

Who may not be able to join:

• People whose cancer is causing symptoms throughout the body or has spread beyond the limited number of spots defined by the trial's progression criteria.
• People in whom visible tumour remained after their second surgery.
• People who still have side effects from previous cancer treatment that are rated above a moderate level of severity.
• People who are unable to swallow oral medications, or who have a serious medical condition that could affect their safety or how their body absorbs the study drug.
• People with significant heart or cardiovascular problems, such as uncontrolled high blood pressure, uncontrolled or symptomatic irregular heartbeat, heart failure, or a heart attack within the past 6 months, or moderate to severe heart disease as classified by standard medical guidelines.
• People who, after previous PARP inhibitor treatment, experienced severe and persistent (lasting more than 4 weeks) low red blood cell count, low white blood cell count, or low platelet count.
• People with a known history of HIV, or an active hepatitis B or hepatitis C infection, or any uncontrolled active infection currently requiring intravenous antibiotics.
• People with a known allergy or sensitivity to niraparib or any of its ingredients.
• People who have received a blood or platelet transfusion, or growth factor injections, or have other abnormal blood results within 2 weeks before starting niraparib, which could affect study results.
• People currently participating in another clinical trial (whether it involves a treatment or observation), until the safety visit for that study is completed. Note: participation in retrospective studies or data analysis is permitted.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study treatment period.
• People with a history of, or features suggesting, certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia).
• People who have previously had a bone marrow transplant or a specific type of stem cell transplant from a donor.
• People who have had another cancer in the past 5 years, unless it was fully treated with no signs of return. Note: certain low-risk or in-situ cancers may still be eligible (confirm with trial site).
• People who have received a live virus vaccine within 28 days before starting study treatment.

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