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 are able to understand the study and are willing to sign a consent form before any study-specific procedures begin.
• Women aged 18 or older at the time of signing the consent form.
• People who have been diagnosed through a tissue sample with a specific type of ovarian, fallopian tube, or primary peritoneal cancer called high-grade serous carcinoma (HGSC).
• People who have previously received platinum-based chemotherapy (at least 4 cycles) and whose cancer has come back or gotten worse either during that treatment or within about 6 months of finishing it — as confirmed by scans or clinical signs, not just a blood marker result alone. (Note: people whose cancer progressed during or within 4 weeks of their very first platinum-based treatment are not eligible, but those whose cancer returned after a later course of platinum-based treatment may still qualify even without 4 cycles — confirm with trial site.)
• People who have received no more than 3 prior rounds of cancer treatment overall. Certain maintenance therapies such as PARP inhibitors, bevacizumab, or hormonal therapies given after a response to platinum-based chemotherapy may not count toward this total (confirm with trial site).
• People who have at least one area of cancer that can be clearly measured on scans according to standard criteria (RECIST 1.1).
• People who are generally well enough to carry out daily activities with little or no limitation, as rated on a standard scale (ECOG score of 0 or 1).
• People who are expected to live for at least 3 months, as assessed by the treating doctor.
• People who can provide a tumour tissue sample — either a stored sample or a newly collected one — during the screening period. A fresh sample taken after the most recent cancer recurrence is preferred.
• People who have recovered from side effects of previous treatments, with most side effects reduced to a mild level or stable. Minor ongoing issues such as hair loss or mild nerve symptoms may still be acceptable (confirm with trial site).
• People whose blood, liver, kidney, and clotting function results fall within the levels required by the trial, tested within 7 days before joining. This includes:
  • Haemoglobin (a measure of red blood cells) at a sufficient level, without recent transfusions or boosting medications in the prior 2 weeks.
  • Platelet counts (cells that help blood clot) at a sufficient level, without recent platelet transfusions in the prior 2 weeks.
  • Neutrophil counts (a type of white blood cell) at a sufficient level, without recent use of cell-stimulating medication in the prior 2 weeks.
  • Liver function results within acceptable ranges.
  • Kidney function within acceptable ranges.
  • Urine protein levels within acceptable ranges.
  • Blood clotting measures within acceptable ranges; people on stable blood-thinning medication may still be eligible (confirm with trial site).
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use reliable contraception during the study and for 3 months after the last dose of study treatment.

Who may not be able to join:

• People who have had major surgery or a significant injury within 28 days before joining, or a diagnostic biopsy within 14 days before joining (though exceptions for biopsy may be considered — confirm with trial site).
• People who have recently received other cancer treatments — including chemotherapy, targeted therapy, immunotherapy, or certain biological medicines — within specified timeframes before joining (ranging from 14 to 28 days depending on the treatment type).
• People who have received radiotherapy within 14 days before joining. A shorter wait of 7 days may apply for limited palliative radiation to areas outside the brain (confirm with trial site).
• People who have previously been treated with a FAK inhibitor or with pegylated liposomal doxorubicin (PLD), which is the study drug being tested.
• People who have had a different type of cancer within the past 3 years, unless it was fully cured — for example, certain early-stage cancers such as cervical carcinoma in situ, breast carcinoma in situ, prostate carcinoma in situ, or basal cell skin cancer may be acceptable (confirm with trial site).
• People with active cancer that has spread to the brain or the lining of the brain. People with previously treated and stable brain metastases may be eligible if their condition has been confirmed stable on repeat scans at least 28 days apart (confirm with trial site).
• People who have had a serious heart, blood vessel, or clotting event — such as a heart attack, stroke, blood clot in the lungs, or deep vein thrombosis — within the past 6 months, or who have certain ongoing heart problems such as a heart rhythm disorder, low heart pumping function, uncontrolled high blood pressure, uncontrolled diabetes, or other significant heart conditions.
• People with significant fluid build-up around the lungs, heart, or in the abdomen that causes symptoms or has required draining in the 3 months before joining. A small amount of abdominal fluid that causes no symptoms and is only visible on scans may be acceptable.
• People who have difficulty absorbing food or medicines through the gut, or who are unable to swallow oral medications.
• People with significant ongoing gut problems such as active Crohn's disease, active ulcerative colitis, or uncontrolled gastrointestinal bleeding.
• People with signs of a bowel blockage, or a history of repeated bowel blockages whose cause has not been ruled out.
• People who currently have interstitial pneumonia (a type of lung inflammation), except for a specific type of stable radiation-related lung scarring that does not require steroid treatment.
• People with an active infection that has not been adequately controlled with treatment.
• People with a known HIV infection, or active Hepatitis B or Hepatitis C infection.
• People with any other medical condition, treatment history, or lab result that the treating doctor believes could affect the study results or make participation unsafe.
• People with a known psychiatric condition or substance use disorder that could make it difficult to participate in the study as required.
• People with a known allergy or sensitivity to either of the study drugs or their ingredients.
• People who have previously received a high cumulative dose (550 mg/m² or more) of a group of chemotherapy drugs called anthracyclines.
• People who are currently taking, or who have taken within the past 14 days, certain medications that strongly affect how the body processes drugs (specifically strong inhibitors or inducers of CYP3A4, CYP2D6, or P-gp), or who are expected to need such medications during the treatment phase.

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