Phase 1 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 been diagnosed with a confirmed recurrent form of epithelial ovarian cancer that has stopped responding to platinum-based chemotherapy (meaning the cancer came back or grew within 6 months of the last platinum chemotherapy dose).
• For the expansion phase of the trial only, people whose cancer is specifically the "high-grade serous" type of ovarian cancer.
• People who have received between 1 and 3 prior systemic (whole-body) cancer treatments.
• Women aged 18 or older.
• People who are reasonably active and able to care for themselves, as measured by a standard medical scale (confirm with trial site).
• People whose blood counts and organ function fall within acceptable ranges, as tested within 28 days before starting treatment — including healthy enough levels of red blood cells, white blood cells, platelets, and measures of liver and kidney function (confirm with trial site for specific values).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have an undetectable viral load while on appropriate treatment, or whose past infection has resolved.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who have had brain metastases (cancer that spread to the brain) that were treated, and whose condition has been stable for at least 4 weeks after radiation and who are no longer on steroid medications.
• People with a known or past history of heart problems, provided their heart function is assessed as Class 2B or better on a standard heart health scale (confirm with trial site).
• People who are postmenopausal, or people of childbearing potential who have a negative pregnancy test within 28 days of starting treatment and who agree to use at least one highly effective form of contraception throughout the trial and for 6 months after the last dose — and whose partner agrees to use a condom.
• For the expansion phase only, people who have at least one tumour that can be safely biopsied.
• People who have not previously been treated with a CDK 4/6 inhibitor (a type of cancer drug). Previous use of a PARP inhibitor is allowed only if it was used as a first-line treatment, not for recurring disease.
• People who have fully recovered from the side effects of previous chemotherapy (with the exception of hair loss or certain nerve-related symptoms), with at least 21 days passed since the last chemotherapy dose.
• People who have fully recovered from the effects of previous radiotherapy, with at least 28 days passed since the last session.
• People who have had at least 4 weeks since completing any other non-chemotherapy cancer treatments (previous use of bevacizumab is allowed).
• People who are able to understand and sign a consent form, or who have a legally authorised representative available to do so on their behalf.

Who may not be able to join:

• People who are currently participating in another clinical trial involving an experimental treatment.
• People who have had a serious allergic reaction to abemaciclib, olaparib, or similar medications.
• People who are currently taking certain medications that interact with the trial drugs, specifically strong or moderate inhibitors of an enzyme called CYP3A (examples include itraconazole, clarithromycin, ciprofloxacin, fluconazole, and others — confirm with trial site for the full list). A 2-week washout period before starting the trial may apply.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding.
• People who have had another cancer diagnosis, unless it was fully treated with no signs of return for at least 5 years — with certain exceptions such as treated non-melanoma skin cancer, cervical cancer in situ, DCIS, or early-stage low-grade endometrial cancer.
• People with certain serious or uncontrolled heart conditions, including abnormal heart rhythms, heart failure, or a condition called long QT syndrome, as shown on a heart tracing (ECG).
• People who have, or show signs of having, a blood disorder called myelodysplastic syndrome or acute myeloid leukaemia.
• People with serious, uncontrolled medical conditions or active infections that the trial doctors determine would make participation unsafe — including examples such as recent heart attack (within 3 months), uncontrolled seizures, severe lung disease, severe kidney impairment, or active inflammatory bowel conditions.
• People who are unable to swallow tablets or capsules, or who have a digestive condition likely to affect how the body absorbs the medications.
• People who have had major surgery within 2 weeks before starting the trial, or who have not yet fully recovered from a recent surgery.
• People who have previously had an allogeneic bone marrow transplant or a double umbilical cord blood transplant.
• People with an active systemic fungal infection.
• People with a history of, or suspected, inflammatory lung disease (interstitial lung disease or pneumonitis).
• People with an active blood clot condition (thromboembolism) diagnosed within the last 6 months, or where clots are still visible on imaging despite treatment. People with a history of blood clots more than 6 months ago who are on ongoing preventive treatment may still be considered eligible (confirm with trial site).

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