Phase 1 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:

• People who are willing to take part, understand what the study involves, and are prepared to sign a consent form.
• People aged 18 or older.
• Postmenopausal women with hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer (confirmed by tissue or cell testing) whose cancer got worse during or after hormone therapy; OR postmenopausal women with HR-positive locally advanced or metastatic ovarian or endometrial cancer whose cancer got worse during or after standard treatment.
• People who have at least one tumour lesion that can be measured or tracked using CT, MRI, or X-ray scans at the start of the study and at follow-up appointments.
• People who are fairly active and able to carry out daily activities, rated 0 or 1 on a standard health performance scale (ECOG scale).
• People who are expected to live for at least 12 weeks.

Who may not be able to join:

• People who currently have brain or nervous system metastases causing symptoms, or cancer that has spread to the membranes around the brain or spinal cord. (Note: people who have already been treated for brain metastases at least 4 weeks before joining, are neurologically stable, and have not needed steroid medication in the 2 weeks before enrolling may still be considered — confirm with trial site.)
• People who have had another type of cancer in the past, unless it was a cured skin cancer (basal cell or squamous cell) or cervical cancer in situ, or unless there has been no sign of that cancer for 3 or more years.
• People who have uncontrolled fluid build-up around the heart, lungs, or abdomen that has not improved with treatment.
• People who have had an organ, bone marrow, or stem cell transplant from another person.
• People with a known allergy or bad reaction to the drug fulvestrant, or people who are generally prone to allergic reactions such as hives, asthma, or swelling under the skin.
• People with significant heart problems, including: severely reduced heart pumping function; a heart rhythm problem with a QTc interval over 480 ms or a hereditary long QT condition; or, within the past 6 months, a heart attack, severe chest pain, heart failure, stroke or mini-stroke, serious blood clots in the lungs, or heart bypass surgery.
• People with known HIV infection or a positive HIV test result at screening.
• People with active hepatitis C or hepatitis B with high virus levels in the blood at screening (people with lower virus levels who agree to take antiviral medication may still be considered — confirm with trial site).
• People who needed intravenous antibiotics for an active infection within 1 week before enrolling.
• People with moderate or severe liver disease (Child-Pugh class B or C).
• People whose blood test results show that certain organs are not working well enough, based on specific laboratory value thresholds for white blood cells, red blood cells, platelets, liver enzymes, bilirubin, and kidney function. (Note: blood transfusions or blood-boosting injections in the 14 days before testing are not permitted when these values are assessed.)
• People who received certain cancer treatments too recently before joining — including chemotherapy, targeted drugs, radiation, immunotherapy, cell therapy, antibody treatments, or certain traditional medicines — each with specific required waiting periods ranging from 1 to 8 months (confirm exact washout periods with trial site).
• People with a bleeding disorder (such as clotting factor problems) or those on long-term anticoagulant (blood-thinning) therapy, excluding low-dose aspirin-type drugs, low-dose warfarin, or low molecular weight heparin.
• People with serious blood clot or vascular blockage problems that required medical or surgical treatment.
• People with active autoimmune diseases that require ongoing systemic treatment such as steroids or immune-suppressing drugs. (Note: thyroid conditions and hormone replacement therapies are generally permitted — confirm with trial site.)
• People who have taken high-dose systemic steroid medications within the 4 weeks before starting the study drug. (Low doses, such as up to 20 mg of prednisone daily or equivalent, are excluded from this restriction.)
• People who had major surgery within 4 weeks before enrolling, or who plan to have major surgery during the study.
• People who have not yet recovered from side effects of previous cancer treatments or surgery to a mild level or better. (Note: stable, long-lasting mild side effects such as nerve tingling or hair loss that are not expected to resolve may be acceptable — confirm with trial site.)
• People whom the trial investigators determine are not suitable to participate for any other reason.

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