Phase 1 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 given written consent to participate before any study procedures begin
• People who have been confirmed by laboratory testing to have recurrent ovarian, fallopian tube, primary peritoneal, endometrial, vaginal, or cervical cancer located in the abdomen or pelvis
• People with cancer that has spread to other parts of the body (stage IV) may still be considered, as long as the disease outside the area to be treated with radiation has not grown for at least 3 months, and immediate chemotherapy is not needed
• People who are willing to stop certain cancer treatments (chemotherapy, immunotherapy, biologic or targeted therapies) at least three weeks before starting the study treatment
• People whose blood test results, taken within 28 days before starting treatment, show that haemoglobin levels are at or above 10.0 g/dL, with no blood transfusions in the 28 days before joining
• People whose blood counts, taken within 28 days before starting treatment, show healthy levels of infection-fighting white blood cells (neutrophils at or above 1.5 x 10⁹/L, and total white blood cells above 3 x 10⁹/L)
• People whose blood tests show no signs of certain serious blood disorders (MDS or AML) within 28 days before starting treatment
• People whose platelet count (cells that help blood clot) is at or above 100 x 10⁹/L within 28 days before starting treatment
• People whose liver function blood tests are within acceptable ranges within 28 days before starting treatment (confirm specific values with trial site)
• People whose kidney function blood test results are within acceptable ranges within 28 days before starting treatment (confirm with trial site)
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical scale (ECOG performance status 0–1), or who have a life expectancy of at least 16 weeks
• People who have a life expectancy of at least 16 weeks
• Women who are not able to become pregnant, or who have a negative pregnancy test within 28 days of starting treatment, confirmed again on the first day of treatment
• Women of childbearing potential who are willing to use two highly effective forms of contraception throughout the study (specific acceptable methods are listed in the criteria; confirm details with trial site)
• People who are willing and able to attend all required study visits, treatments, and follow-up appointments
• People who have at least one area of cancer that has not been previously treated with radiation, that can be clearly measured on a CT or MRI scan (at least 10 mm in size, or at least 15 mm for lymph nodes)
• People who consent to providing tumour tissue samples for research purposes may be included in an additional part of the study — however, declining this part does not affect eligibility for the main study

Who may not be able to join:

• People who have fluid build-up in the abdomen (ascites), widespread cancer throughout the abdominal lining (peritoneal carcinomatosis), or cancer that has spread to the liver
• People who have previously had radiation therapy to the area of the body being considered for treatment in this trial
• People who have received chemotherapy, radiation, hormone therapy, immunotherapy, or another experimental treatment within the 3 weeks before starting this trial
• People who have previously taken part in this same study
• People who are currently taking part in another clinical trial involving an experimental treatment within the last 4 weeks
• People who have a second, separate cancer — with some exceptions, such as certain skin cancers, cervical cancer in situ that was fully treated, or other cancers that were fully treated with no sign of return for 5 or more years (requires discussion with the study doctor)
• People who are currently receiving systemic chemotherapy or radiation therapy
• People who are currently taking certain medications that affect how the body processes drugs, including specific antifungal or antiviral medicines (such as ketoconazole, itraconazole, ritonavir, and others listed in the criteria — confirm full list with trial site)
• People taking certain other medications that affect drug transport in the body (P-gp inhibitors, P-gp inducers, or BCRP inhibitors — confirm full list with trial site), unless those medications can be stopped before joining
• People who still have ongoing side effects from previous cancer treatment rated at a moderate level or above (grade 2 or higher), except for hair loss
• People whose heart's electrical activity test (ECG) shows a prolonged interval (QTc above 470 milliseconds) on two or more occasions within 24 hours, or who have a family history of a heart rhythm condition called long QT syndrome
• People who have been diagnosed with certain serious blood disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms and are not under control
• People who have had major surgery within 14 days before starting the study, or who have not fully recovered from a recent major surgery
• People who have serious, uncontrolled medical conditions such as uncontrolled heart rhythm problems, a heart attack within the past 3 months, unstable spinal cord compression, superior vena cava syndrome, serious lung disease, or a psychiatric condition that prevents giving informed consent
• People who cannot swallow tablets or capsules, or who have a digestive condition that would prevent the study medication from being properly absorbed
• People who are currently breastfeeding
• People who have a known allergy to the study drug (talazoparib) or any of its ingredients
• People who have seizures that are not controlled
• People whose cancer requires radiation to be delivered to a broader region of the abdomen and lower spine (pelvic and para-aortic radiation at the L1/T12 level)
• People whose cancer has returned only in the vagina, with no involvement of lymph nodes or other areas of the pelvis or abdomen

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