Phase 2 Pancreatic 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 been diagnosed with pancreatic adenocarcinoma (a type of pancreatic cancer) that has spread to other parts of the body, confirmed by a tissue or cell sample.
• People who are 18 years of age or older.
• People who are able to understand what the study involves and are willing to give written consent to take part.
• People who have completed 8 to 12 cycles (roughly 4 to 6 months) of a first-line chemotherapy regimen called FOLFIRINOX, modified FOLFIRINOX, or a similar regimen called NALIRIFOX, and whose cancer has remained stable or improved during that treatment. People who had to stop one component of these regimens (oxaliplatin) due to side effects may also be considered.
• People whose cancer has shown at least stable results on imaging and stable or improving tumour markers, as assessed by the treating doctor.
• People who are willing to have a tumour biopsy taken before treatment begins, if this is considered medically safe.
• People who are willing to have a tumour biopsy taken during treatment, if this is considered medically safe.
• Women of childbearing potential who have a negative pregnancy test within 24 hours before starting study treatment, and who agree to use effective contraception from the time of screening until 6 months after the last dose.
• Men who agree to use effective contraception from the first dose until 90 days after the last dose.
• People whose blood test results, taken within 7 days before starting treatment, show that the bone marrow, liver, and kidneys are functioning at an adequate level (confirm specific values with the trial site).
• People with an ECOG performance status of 0 or 1, meaning they are either fully active or have mild restrictions in physically strenuous activity but are able to carry out light work (confirm with trial site).

Who may not be able to join:

• People who have previously been treated with a PARP inhibitor, ipilimumab, or another type of drug called a CTLA-4 inhibitor.
• People whose cancer showed resistance to FOLFIRINOX treatment.
• People who are known to carry certain gene changes (in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D) that affect DNA repair, whether inherited or found in the tumour.
• People whose cancer has a specific genetic feature known as mismatch repair deficiency or microsatellite instability-high (MSI-H).
• People with uncontrolled problems absorbing food, or other digestive conditions that could interfere with how the study medication is absorbed, in the opinion of the treating doctor.
• People with uncontrolled high blood pressure (blood pressure consistently above 140/90 mmHg).
• People with a prior history of a condition called posterior reversible encephalopathy syndrome (PRES) — a serious brain condition (confirm with trial site).
• People who have had an active infection requiring intravenous antibiotics, antiviral, or antifungal treatment within the 14 days before the first dose.
• People with a history of, or currently active, autoimmune disease — such as inflammatory bowel disease, rheumatoid arthritis, lupus, scleroderma, autoimmune vasculitis, or certain nerve conditions — though some milder autoimmune conditions such as vitiligo, well-controlled type 1 diabetes, or thyroid conditions only needing hormone replacement may be considered (confirm with trial site).
• People with a history of interstitial lung disease (scarring or inflammation of the lungs) or currently active non-infectious lung inflammation.
• People who have received a live vaccine within 4 weeks before the first dose (note: standard injected flu vaccines are generally allowed, but nasal spray flu vaccines are not).
• People of childbearing potential who are unwilling to use effective contraception during the trial and for the required period after the last dose.
• People who have received any systemic cancer treatment within 14 days before the first dose, or any experimental treatment within 4 weeks (or within a period based on how long the experimental drug stays in the body, whichever is longer).
• People who require ongoing treatment with higher-dose corticosteroids (such as prednisone above 10mg per day) or other immune-suppressing medications within 14 days of starting the study drug, unless it is for an inhaled, topical, or replacement-dose purpose and there is no active autoimmune disease.
• People who experienced severe (Grade 3 or 4) low red blood cells, low white blood cells, or low platelets due to prior chemotherapy that lasted more than 4 weeks and was related to their most recent treatment.
• People who have had a minor surgical procedure within 5 days, or a major surgical procedure within 21 days, before the first dose, or who have not sufficiently recovered from surgery.
• People with active drug or alcohol use or dependence that would affect their ability to follow the study requirements.
• People with any other condition that the treating doctor believes would make participation unsafe or affect the study results.
• People with a known history of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) — two types of blood or bone marrow conditions.
• People who are currently enrolled in another treatment-focused clinical trial.
• People who have had radiotherapy within 4 weeks before the first dose.
• People with a known allergy or sensitivity to niraparib or any of its ingredients.
• People who have received a blood transfusion (red blood cells or platelets) within 4 weeks before the first dose.
• People who are currently receiving treatment for another active cancer, with some exceptions — for example, certain skin cancer treatments or hormonal therapies for breast or prostate cancer with no signs of active disease may be permitted (confirm with trial site).
• People with a history of certain other cancers may still be considered eligible if those cancers were treated and have shown no signs of return (confirm specific history with trial site).
• People with active hepatitis B or hepatitis C infection, confirmed by a specific blood test (PCR).
• People with HIV may be considered, but only if their viral load is undetectable and they are on a stable HIV treatment regimen at the time of enrolment.
• People with known, symptomatic spread of cancer to the brain or the lining of the brain or spinal cord.

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