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 high-grade serous (or mostly serous) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back for the first time and is still responding to platinum-based chemotherapy, with at least 6 months of no cancer growth since their last platinum treatment.
• People who have had genetic testing done, with at least their BRCA1/2 mutation status known, and/or tumor testing for DNA repair problems (HRD or LOH).
• People who are enrolled in the trial between 3 and 8 weeks after starting the last cycle of their current platinum-based chemotherapy for this first recurrence.
• People who received at least 3 cycles of bevacizumab (a targeted therapy) during chemotherapy and have a plan to continue it as ongoing maintenance treatment.
• People whose cancer has shown a partial or complete response to their current platinum-based chemotherapy, confirmed by scans or a blood marker called CA-125.
• People who are 18 years of age or older.
• People who are reasonably active and able to carry out daily activities (this is measured by a medical scale called ECOG, and a score of 0–2 is required — confirm with trial site).
• People whose liver function, kidney function, and blood counts (including white blood cells, platelets, and haemoglobin) meet specific minimum levels as measured by blood tests.
• People whose blood pressure is adequately controlled (below 160/100 mmHg).
• People who, if they could become pregnant, have a negative pregnancy test within 7 days before starting the study treatment.
• People who, if they could become pregnant, agree to use effective contraception during the study and for at least 6 months after stopping study treatment.
• People who, if taking narcotic pain medications, have been on a stable dose for at least 2 weeks before joining.
• People who are able to stop taking statin medications within 48 hours of starting the study treatment.
• People whose heart's electrical activity (measured by an ECG) shows a QT interval of less than 450 milliseconds.
• People with diabetes whose blood sugar is well controlled (HbA1c below 8%).
• People who are able to provide voluntary, signed, and dated informed consent as required by the institution.

Who may not be able to join:

• People with serious heart disease (classified as NYHA Class III or IV), a heart attack in the past 6 months, an unstable heart rhythm, or signs of reduced blood flow to the heart on a baseline ECG.
• People who have been hospitalised for a psychiatric condition within the last two years.
• People with a significant neurological condition such as Parkinson's disease, dementia, or multiple sclerosis, as assessed by the trial doctor.
• People whose cancer is resistant or does not respond to platinum-based chemotherapy.
• People with an active, uncontrolled infection (bacterial, viral, or fungal) that requires treatment.
• People who have had radiation therapy, surgery, or another experimental treatment within 28 days before joining (except for the platinum chemotherapy and bevacizumab being used in this trial).
• People who are unwilling or unable to follow the procedures required by the trial.
• People with a serious non-cancer condition that the trial doctor believes would interfere with the study.
• People currently taking the blood thinner warfarin (also called Coumadin).
• People currently participating in another clinical trial of an experimental treatment.
• People with any mental health condition that the enrolling doctor determines would prevent safe participation in the study.
• People who are prisoners or who are involuntarily held for psychiatric or other medical treatment.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months of the last dose of study treatment.
• People who are unable to stop taking certain medications that affect how the body processes drugs (specific enzyme pathways called CYP2C8, CYP3A4, CYP2C19, CYP2D6, FMO-1, MAO-A, P-gp, MATE1K, and MATE2K — confirm with trial site which medications are affected).
• People diagnosed with myasthenia gravis (a muscle weakness condition).
• People with a condition called G6PD deficiency (an inherited enzyme disorder).
• People with porphyria (a group of rare metabolic disorders).
• People whose cancer would normally make them a candidate for a type of maintenance treatment called a PARP inhibitor — unless they previously tried a PARP inhibitor and could not tolerate it, and have chosen not to pursue that treatment.
• People who have medical reasons why they cannot receive bevacizumab, as outlined in the medication's approved prescribing information.
• People with a high calculated cardiovascular risk score (using the American College of Cardiology ASCVD Risk Estimator) for whom stopping statin medication would be medically unsafe.

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