Phase 2 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:

• Adults aged 18 or older
• People who have been diagnosed through a tissue biopsy with a specific type of ovarian cancer called high grade serous carcinoma, which may have started in the ovaries, fallopian tubes, or the lining of the abdomen
• People whose cancer came back after initially responding well to platinum-based chemotherapy (meaning there was a gap of at least 6 months before the cancer grew again), but the cancer has since stopped responding to platinum-based treatment
• People who have had no more than one previous treatment specifically for the platinum-resistant stage of their cancer (previous PARP inhibitor therapy is allowed)
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1)
• People whose cancer can be safely biopsied twice during the trial
• People expected to live at least 12 weeks
• People who are reasonably well and able to carry out daily activities (assessed using a standard scale called ECOG, at level 0, 1, or 2)
• People whose recent blood test results (taken within the past 28 days) show that blood counts, liver function, and kidney function are within acceptable ranges for the trial
• People of childbearing potential who have had a negative pregnancy test within 7 days before joining
• People who are willing to sign a consent form agreeing to take part
• People who are able to return to the enrolling hospital or clinic for follow-up visits during the active monitoring phase
• People who are willing to provide blood samples for research purposes
• People who are willing to provide tissue samples for research purposes

Who may not be able to join:

• People who are pregnant
• People who are currently breastfeeding
• People of childbearing potential who are unwilling to use adequate contraception (this trial involves a drug known to carry risks of harm to an unborn child)
• People whose cancer is a type other than high grade serous carcinoma
• People who have received chemotherapy, immunotherapy, radiation therapy, or another experimental treatment within the 4 weeks before joining
• People who have had another cancer diagnosis within the past 2 years, unless that cancer or its treatment is considered unlikely to affect the safety or results of this trial (confirm with trial site)
• People with serious uncontrolled health conditions, including a heart attack within the past 6 months, severe heart failure (NYHA class III or IV), uncontrolled heart rhythm problems, or poorly controlled chest pain
• People with known heart disease or a history of treatment with drugs that can damage the heart, unless a heart function assessment places them at class IIB or better on the standard heart classification scale — people who have previously received a drug called doxorubicin (Doxil) may still be considered if they have no heart symptoms and meet specific heart measurement criteria (confirm with trial site)
• People with HIV, unless they are on effective HIV treatment with an undetectable viral load within the past 6 months
• People with known hepatitis B or C, unless the virus is undetectable and/or the infection has been successfully treated under conditions specified by the trial (confirm with trial site)
• People currently taking part in another clinical trial involving an experimental treatment
• People with a history of significant gastrointestinal bleeding, bowel inflammation (colitis), or a hole in the bowel (perforation)
• People with other serious ongoing illnesses that, in the opinion of the trial doctor, would make participation unsafe or affect how well the trial can assess the treatment
• People who require blood-thinning medication that raises certain clotting test results above the normal range (low-dose preventive blood thinners for clots may be allowed — confirm with trial site)
• People with known disease affecting the brain or spinal cord lining, unless the brain disease has been treated and shows no sign of growth on follow-up scans, or the treating doctor determines that urgent brain-directed treatment is not needed during the first treatment cycle (confirm with trial site)
• People known to have a condition called Gilbert's syndrome, or who carry a specific genetic variation that significantly reduces the body's ability to process the trial drug
• People who need to take certain medications that interfere with how the body processes the trial drug (known as UGT1A1 inhibitors) during the trial treatment period

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