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 given written consent to take part before any screening tests are done (or whose legal representative has done so on their behalf).
• People who are using a highly effective form of contraception, such as implants, injections, combined oral contraceptive pills, certain IUDs, a vasectomised partner, or complete abstinence from heterosexual sex throughout the treatment period.
• People with a confirmed tissue diagnosis of a specific type of ovarian, fallopian tube, or peritoneal cancer — specifically low-grade serous carcinoma, low-grade endometrioid carcinoma, or adult-type granulosa-cell tumour — where laboratory testing has shown the tumour is oestrogen receptor (ER) positive. The diagnosis must be confirmed by a specialist gynaecological pathologist as part of screening.
• People whose prior treatment history meets specific requirements depending on which stage of the trial they would enter: in both Stage 1 and Stage 2, certain patients must still be eligible to receive platinum-based chemotherapy, with no limit on the number of prior chemotherapy regimens but no more than 2 prior hormone therapy regimens. A separate group of 15 patients in Stage 2 may be eligible even if platinum is no longer an option, under the same chemotherapy and hormone therapy limits. People who have previously received chemotherapy for platinum-resistant or refractory disease are not eligible (confirm with trial site).
• People aged 18 or over at the time of joining the trial.
• People who are generally well enough to carry out light daily activities, as measured by a standard medical fitness scale (ECOG performance status 0 or 1).
• People whose cancer has returned and can be measured on imaging (CT or MRI) or physical examination, with at least one tumour lesion meeting specific size requirements.
• People who are willing and able to provide tissue samples (from stored tissue or a new biopsy) and blood samples for research purposes as part of the trial.
• People who have previously been treated with letrozole or another aromatase inhibitor (a type of hormone therapy) may be eligible, though the number of such patients in each group is limited to 10.
• People who have had radiotherapy, provided they have fully recovered from its side effects and at least 14 days have passed since their last radiotherapy treatment.
• People who no longer have active ovarian function, or whose ovarian function has been confirmed by blood tests. People who still have ovarian function may be eligible, but would need to receive hormonal suppression treatment and have a negative pregnancy test first.
• People whose blood test results meet minimum thresholds for blood cell counts, kidney function, liver function, and related measures, as assessed during screening.

Who may not be able to join:

• People with platinum-refractory disease (cancer that did not respond to platinum-based chemotherapy). In Stage 1, people for whom platinum is not an option at all are also excluded. People who have received chemotherapy must have recovered from most of its side effects before joining (with some exceptions for hair loss or mild nerve-related symptoms).
• People with serious pre-existing health conditions that could make participation unsafe, such as certain lung conditions, severe breathlessness, very poor kidney function, a history of major stomach or bowel surgery, Crohn's disease, ulcerative colitis, or a long-term condition causing frequent diarrhoea.
• People currently taking certain medicines or foods that are known to strongly affect the way the body processes the trial drugs (specific examples would be discussed with the trial site).
• People who have been diagnosed with another cancer within the past 3 years, except for certain treated skin cancers or early-stage cervical abnormalities.
• People who have previously received a type of cancer treatment called a CDK inhibitor.
• People with a known current infection with Hepatitis B, Hepatitis C, or HIV.
• People who are unable or unwilling to swallow tablets or capsules.
• People who have had major surgery within 14 days before starting the trial, or who have not yet recovered from major surgery (routine tumour biopsy is not considered major surgery).
• People who have an active infection currently being treated with intravenous antibiotics or antifungal medicines, or another serious ongoing illness requiring hospital care.
• People with a history of fainting due to a heart-related cause, dangerous heart rhythm problems, or sudden cardiac arrest.
• People who have previously had a stem cell or bone marrow transplant.
• People with brain metastases (cancer that has spread to the brain) that may still be active. People with previously treated brain metastases may be considered, provided the lesions have been stable for at least 12 weeks with no signs of new or growing metastases.
• People with known blood clotting disorders, or who are taking blood-thinning medicines in a way that would prevent intramuscular injections being given safely (if that injection is required as part of treatment).
• People with a known or suspected allergy to letrozole, abemaciclib, or any of their ingredients.
• People who have not yet reached menopause and have a known allergy to a type of hormone medicine called a GnRH agonist.
• People who are pregnant or breastfeeding.
• People who are currently taking part in another clinical trial involving an investigational medicine or device, or who have received an experimental treatment within the last 30 days or 5 half-lives of that treatment (whichever is longer) before joining.

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