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 been newly diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer at an advanced stage (FIGO stage III or IV).
• People aged between 18 and 70 years.
• People whose cancer type has been confirmed through a biopsy (via keyhole surgery or a needle sample) as a high-grade or certain specific cancer types, including serous carcinoma, endometrioid carcinoma, fallopian tube cancer, or primary peritoneal cancer.
• People whose general health and ability to carry out daily activities falls within a certain range on a standard medical scale (ECOG performance status of 0 or 1, meaning fully active or able to carry out light activity).
• People whose tumour or blood test shows a specific genetic abnormality called homologous recombination deficiency (HRD) — this relates to how the body repairs DNA damage (confirm with trial site).
• People who have at least one tumour area that can be measured on a CT or MRI scan.
• People who are not suitable for upfront surgery to remove the tumour, either because complete removal would not be possible or because surgery carries too high a risk — assessed using specific scoring systems or health factors such as high body weight (BMI ≥40), multiple ongoing health conditions, malnutrition, significant fluid build-up in the abdomen, or a recent blood clot in a vein.
• People with a life expectancy of more than 3 months.
• People whose blood and organ function test results (including blood counts, liver function, kidney function, clotting, and urine protein) fall within the acceptable ranges required by the trial, measured within 7 days before treatment starts.
• People whose heart rhythm measurement (a specific interval on an ECG called QTcF) is below 470 milliseconds.
• Women who could become pregnant must have a negative pregnancy test within one week before joining and must agree to use effective contraception throughout the study.
• People where any side effects from previous chemotherapy have cleared up to a mild level or returned to their normal baseline (with exceptions for mild nerve-related symptoms or hair loss).
• People who agree to take part voluntarily, sign a consent form, and attend follow-up visits.

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug or any of its ingredients.
• People who are receiving or plan to receive other cancer treatments at the same time, such as chemotherapy, radiation, immunotherapy, or certain herbal/traditional medicines.
• People who cannot swallow tablets or capsules, or who have digestive conditions that could affect how the study drug is absorbed, such as uncontrolled nausea and vomiting, bowel obstruction, or poor nutrient absorption.
• People who have previously received any treatment for ovarian cancer.
• People who have previously been treated with a type of drug called a PARP inhibitor or a drug that targets blood vessel growth (anti-angiogenic therapy).
• People who have cancer that has spread to the brain and is causing symptoms or requires active treatment, or who have signs of pressure on the spinal cord.
• People with a history of serious blood clots in the veins or in the lungs (pulmonary embolism).
• People who have received other targeted cancer medicines within the 4 weeks before joining the trial.
• People who have had major surgery within one month before the trial starts, or who have not yet fully recovered from a previous surgery.
• People who have had another type of cancer within the past 3 years, except for certain fully treated skin cancers, a specific early form of breast cancer (ductal carcinoma in situ), or cervical carcinoma in situ.
• People who have been diagnosed with certain blood or bone marrow conditions called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People with serious uncontrolled health conditions, including active HIV, untreated hepatitis B or C, severe heart problems, uncontrolled seizures, serious psychiatric conditions that affect the ability to give consent, uncontrolled high blood pressure, or conditions that significantly weaken the immune system.
• People with HIV infection, AIDS, untreated active hepatitis B, or active hepatitis C infection.
• People who have received an organ transplant or bone marrow transplant during the study (corneal transplants are an exception).
• People who are currently taking part in another interventional clinical trial, or who have received another experimental drug or device within the 4 weeks before joining, or who have not yet recovered from side effects of a previous trial.
• People with uncontrolled high blood pressure (readings at or above 160/110 mmHg despite treatment).
• People with abnormal blood clotting test results, a history of abnormal bleeding, or who are currently taking blood-thinning or clot-dissolving medicines.
• People whose urine tests show an abnormal level of protein (confirmed by a 24-hour urine protein test showing 1.0 g or more).
• People with a history of substance abuse involving mind-altering drugs that cannot be stopped, or people with a psychiatric disorder.
• People with a personal or inherited history of bleeding disorders or problems with blood clotting (confirm with trial site).
• People who are currently taking certain medicines that strongly affect how the body processes drugs — specifically, strong or moderate inhibitors or inducers of a liver enzyme called CYP3A4. Examples include itraconazole, clarithromycin, ciprofloxacin, fluconazole, rifampin, phenytoin, and others. A waiting period off these medicines may be required before joining (confirm with trial site).
• People who have had a stroke or a transient ischaemic attack (sometimes called a "mini-stroke") within the past 6 months.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with other serious medical, psychiatric, or laboratory conditions that the trial doctors consider would make participation unsafe or unsuitable.

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