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 read, understood, and signed the informed consent form before any study procedures begin.
• People who are older than 18 years of age.
• People with a life expectancy of at least 3 months.
• People who have been diagnosed with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, confirmed through laboratory analysis of tumour tissue.
• People whose cancer has come back (recurred) and for which no treatment with curative intent is known or available.
• People who are able to provide a stored tumour tissue sample (a preserved tissue block or at least 20 unstained slides); if no stored sample is available, a willingness to have a new tumour biopsy taken at screening (if medically feasible) is required.
• People who have completed at least 2 previous chemotherapy treatment courses for platinum-sensitive disease (meaning the cancer responded for more than 6 months), with the last course finished more than 4 weeks before starting the trial, and with imaging confirming the cancer has progressed.
• People whose cancer has remained sensitive to platinum-based chemotherapy (such as carboplatin, cisplatin, or oxaliplatin), based on scan or tumour marker response to their most recent platinum treatment, or who showed disease progression while taking a PARP inhibitor as a previous therapy.
• People who previously received a PARP inhibitor, whether as a treatment for recurrent disease or as maintenance therapy after prior treatment.
• People who agree to have their tumour tested for HRD (a measure of DNA repair problems in the tumour) and for a specific gene mutation (somatic BRCA) at screening.
• People who agree to provide blood samples at the start and end of treatment for genetic analysis.
• For Phase 2 participants only: people whose cancer has measurable areas of disease visible on imaging scans, as assessed by the trial investigators.
• People with a good general level of physical functioning, rated 0 or 1 on a standard oncology scale (meaning fully active or able to carry out light activity).
• People whose blood test results taken within 14 days of starting treatment show healthy enough levels of white blood cells, red blood cells, haemoglobin, and platelets (specific thresholds apply; the trial site can confirm).
• People whose liver function blood test results are within acceptable ranges within 14 days of starting treatment (specific thresholds apply, including higher allowances for those with known liver metastases or a condition called Gilbert's syndrome).
• People whose kidney function is adequate, with a creatinine clearance of at least 50 mL/min as calculated or measured by a standard formula.
• People who are willing and able to follow the study procedures and attend follow-up appointments.
• People who could become pregnant must have a negative blood pregnancy test within 3 days of starting the study drug, and all participants for whom pregnancy is possible must agree to use highly effective contraception during the study and for 6 months after the last dose, with monthly pregnancy testing required during the study. Highly effective contraception methods include combined hormonal contraception (oral, vaginal, or patch), progestogen-only hormonal contraception (oral, injectable, or implant), an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomised partner, or sexual abstinence.
• People who are considered not at risk of pregnancy include those who have had a tubal ligation, a hysterectomy, or who have been post-menopausal for at least 1 year without periods.
• People who agree not to donate blood during the study or for 90 days after the last dose of study treatment.

Who may not be able to join:

• People who have received any other cancer treatment, including immunotherapy, within 4 weeks before the first dose of the study drug.
• People who have had major surgery within 28 days, or minor surgery within 7 days, of starting study treatment (placement of a port-a-cath is not subject to this restriction).
• People who have had radiotherapy and have not yet fully recovered from its immediate side effects; a gap of at least 14 days between finishing radiotherapy and joining the trial is required.
• People who experienced a serious blood-related side effect (grade 3 or higher) from prior chemotherapy that lasted more than 4 weeks.
• People with uncontrolled high blood pressure as defined by standard medical criteria.
• People who still have side effects from prior treatment rated above grade 1 in severity (other than hair loss or reduced appetite) that would prevent starting a new treatment.
• People who are unable to swallow oral medications, or who have digestive system conditions likely to affect how the study medication is absorbed; people who have a feeding tube (PEG) or are receiving nutrition through a drip (total parenteral nutrition) are also excluded.
• People with active central nervous system (brain or spinal cord) disease, other than brain metastases that have been treated and have been stable (with no growth or bleeding) for at least 28 days after treatment, and where steroid medication for brain metastases has been stopped for at least 14 days before joining the trial.
• People who regularly take certain medications that interact with a liver enzyme called CYP3A4 (a narrow therapeutic index or moderate-to-strong inhibitor/inducer), if those medications cannot be stopped at least 2 weeks before starting the trial drug and kept stopped throughout; the anti-nausea medications aprepitant and fosaprepitant are also prohibited during the study (confirm specific medications with the trial site).
• People who are using herbal supplements — including St. John's wort, kava, ephedra, ginkgo biloba, DHEA, yohimbe, saw palmetto, ginseng, grapefruit, or Seville orange — unless these are stopped at least 7 days before the first dose.
• People with a known allergy or medical reason to avoid any of the study drugs.
• People who currently have, or have had within the last 6 months, certain serious heart conditions including unstable angina, heart failure, a heart attack, an uncontrolled heart rhythm problem, or significant irregular heartbeat (people with well-controlled atrial fibrillation and no other heart problems may still be eligible — confirm with trial site).
• People who have a personal history of fainting due to a heart cause, a dangerous irregular heartbeat originating in the lower chambers of the heart, or sudden cardiac arrest.
• People whose heart's electrical activity (QT interval, measured using a specific calculation) is above a certain threshold on an ECG, or who have a congenital or acquired condition causing a prolonged QT interval.
• People with serious or uncontrolled pre-existing medical conditions that the investigator believes would make participation unsafe, such as interstitial lung disease, severe breathlessness at rest or requiring oxygen therapy, severely reduced kidney function, a history of major removal of part of the stomach or small bowel, or pre-existing Crohn's disease, ulcerative colitis, or any chronic condition causing persistent moderate-to-severe diarrhoea.
• People who are currently pregnant or breastfeeding; female patients must not breastfeed or store breast milk during treatment or within 30 days of the final dose of the study drugs.
• People with a serious active infection at the time of joining, or another serious underlying medical condition that would prevent them from receiving the study treatment.
• People who have had another active invasive cancer in the past 24 months, other than certain non-invasive skin cancers or in-situ carcinomas (such as those of the breast, cervix, bladder, or skin) that have been definitively treated.
• People whose personal, family, social, or geographic circumstances would prevent them from following the study protocol.
• People who have, or are suspected to have, a blood condition called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML).
• People who have previously had an allogeneic bone marrow transplant or double umbilical cord blood transplant.
• People with a history of HIV infection.
• People with active hepatitis B (HBV) or hepatitis C (HCV) infection; people whose hepatitis is controlled with antiviral therapy may still be eligible (confirm with trial site).
• People who have had a stroke, a condition called posterior reversible encephalopathy syndrome (PRES), a pulmonary embolism (blood clot in the lungs), or an untreated deep vein thrombosis (blood clot in a vein) within the past 6 months.
• People who have received an experimental treatment in another clinical trial within the last 30 days or 5 half-lives of that treatment (whichever is longer) before joining, or who are currently participating in another medical research study considered incompatible with this trial.

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