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:

• Women aged 18 or older who have been diagnosed with low-grade serous ovarian or peritoneal cancer, confirmed by a tissue biopsy reviewed by the trial institution's pathology team. Women who previously had a borderline serous tumour (without prior cancer treatment) and have now been newly diagnosed with low-grade serous ovarian cancer may also be considered.
• People whose cancer has been assessed by a specialist gynaecological cancer surgeon as not suitable for primary surgery, or who have already had surgery to remove the tumour but have measurable cancer remaining afterwards.
• People whose cancer can be measured on a scan (CT or MRI), with at least one area of disease measuring 10mm or more, or lymph nodes measuring 15mm or more.
• People who are generally well enough to carry out daily activities, rated on a standard health scale (ECOG score of 0 or 1). People with a slightly lower function score (ECOG 2) may be considered if the reduced function is caused by the cancer itself, not by other health conditions.
• People who have had brain metastases (cancer that has spread to the brain) that have already been treated, with no sign of the cancer growing there on follow-up scans. People with brain metastases that are causing no symptoms and do not need treatment may also be considered.
• People living with HIV who are on effective antiviral medication and have had an undetectable level of virus in their blood within the last 6 months.
• People with a history of hepatitis B virus (HBV) who are on suppressive therapy and have an undetectable level of the virus in their blood.
• People with a history of hepatitis C virus (HCV) who have completed treatment and been cured, or who are currently on hepatitis C treatment with an undetectable viral load.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's assessments (confirm with trial site).
• Women who are able to become pregnant and agree to use a highly effective, non-hormonal form of contraception during the trial and for one month after the last dose of the study treatment — for example, an intrauterine device (IUD), tubal occlusion, a vasectomised partner, or sexual abstinence. A negative pregnancy test within 14 days before starting treatment is also required.
• People with adequate heart function, with the heart's pumping ability measured at 50% or higher on a heart scan (echocardiogram or MUGA scan).
• People whose heart's electrical activity (specifically the QTc interval) is below a certain threshold (under 460 ms) on a heart tracing (ECG). This requirement does not apply to people with a specific type of heart conduction abnormality called a bundle branch block.
• People whose blood counts, liver function, kidney function, and muscle enzyme levels (CPK) fall within acceptable ranges as defined by the trial (confirm specific values with the trial site).

Who may not be able to join:

• People whose treating specialist considers them to be a suitable candidate for primary tumour removal surgery, unless measurable disease remained after that surgery was performed.
• People who have previously received any systemic (whole-body) cancer treatment — such as chemotherapy or hormonal therapy — for low-grade serous ovarian cancer or borderline serous disease.
• People who have had major surgery within the past 4 weeks, minor surgery within the past 2 weeks, or palliative radiotherapy within the past week before starting the trial treatment.
• People currently taking the blood-thinning medication warfarin. Switching to a different type of blood thinner (such as low-molecular-weight heparin or a direct oral anticoagulant) may be an option (confirm with treating doctor and trial site).
• People who are unable to swallow oral medications, or who have significant problems absorbing medication through the digestive system due to stomach removal or a drainage feeding tube. People who have had a bowel obstruction within the past 3 months are also excluded, unless the obstruction has been fully resolved by surgery or the trial site approves their participation.
• People who have brain metastases that are currently causing symptoms and require steroids or other active treatment. People found to have new, symptom-free brain metastases during the trial screening process must first receive radiation or surgery for those metastases before eligibility can be reconsidered.
• People with a history of certain eye conditions that increase the risk of a blockage in the blood vessels of the eye (retinal vein occlusion), including retinal disease, high eye pressure (above 21 mm Hg), or other significant structural eye abnormalities.
• People with a history of certain serious conditions affecting the surface of the eye, including corneal erosion, corneal degeneration, or active or recurring inflammation of the cornea (keratitis).
• People with a history of a serious muscle breakdown condition called rhabdomyolysis.
• People who have had a serious allergic reaction to any of the active or inactive ingredients in the study medications (avutometinib or defactinib).
• Women who are currently breastfeeding.
• People with other significant medical conditions — such as heart, digestive, lung, psychiatric, neurological, or genetic conditions — that the investigator believes would put them at too high a risk of serious side effects.
• People who have used certain medications, supplements, herbal remedies, or foods within 14 days before starting the trial that are known to interact with the study drugs. This includes substances that strongly affect particular liver enzymes (CYP3A4 or CYP2C9) or a drug transport protein called P-glycoprotein (confirm specific substances with the trial site).

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