Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT02127151
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Histologically confirmed endometrial cancer. All histological subtypes except for carcinosarcoma are eligible
* Evidence of inoperable, advanced, recurrent or metastatic disease by imaging and/or histological criteria
* ≤ 1 previous line of systemic cancer therapy for inoperable, advanced, recurrent or metastatic endometrial cancer. Chemotherapy in the adjuvant setting is not considered a prior line of therapy unless recurrence occurred during adjuvant treatment or ≤ 6 months after the last treatment; first line treatment of advanced disease must include at least one cytotoxic agent to be considered as a line of therapy; prior hormonal treatment is not considered a line of therapy in any setting
* Written informed consent obtained prior to any screening procedures
* Patients must give consent for provision of archival histological tissue for the purposes of translational research. If archival tissue is not available or is of insufficient quantity and/or quality, the patient will have the option to consent to undergo biopsy where feasible. If biopsy is not feasible or the patient does not give consent for biopsy when archival tissue is not available, the patient will not be eligible for the trial. The quality and quantity of archival tissue will be assessed by a suitably qualified individual, usually a histopathologist, at site to ensure adequate tissue sample available for testing PTEN, MSI and MRE11
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* Life expectancy ≥ 12 weeks
* Patient has at least one site of measurable disease on radiological imaging (i.e. target lesion) as per RECIST v1.1
* Evidence of non-childbearing status and must not be lactating OR must have postmenopausal status
* Adequate bone marrow and organ function
Exclusion Criteria:
* Prior treatment with a poly adenosine diphosphate ribose polymerase (PARP) inhibitor
* Progressive disease ≤ 3 months after platinum-based chemotherapy
* Active uncontrolled infection including known Hepatitis B, Hepatitis C or HIV
* Obstruction of the gastrointestinal tract or other reason preventing effective oral administration of medication
* Serious concomitant non-malignant disease, uncontrolled organ dysfunction or medical disorder considered by the Investigator to make the subject unsuitable for trial participation including any psychiatric disorder that prevents informed consent
* Significant active cardiovascular disease
* Symptomatic brain metastases
* Immunosuppressant therapy or considered to be otherwise immunocompromised
* Myelodysplastic syndrome/acute myeloid leukaemia
* Major surgery ≤ 28 days prior to registration, or ongoing clinically significant post-surgical complications
* Chemotherapy, radiotherapy (a single fraction of palliative radiotherapy is allowed provided that the site being treated is not subsequently used as a target lesion as per RECIST v1.1 for the purpose of assessing tumour response on trial), immunotherapy or other investigational therapy for cancer ≤ 21 days prior to registration (42 days for nitrosoureas, mitomycin-C)
* Unresolved clinically significant toxicities from prior systemic therapy
* Known hypersensitivity to any of the agents or excipients to be administered
* Unwillingness or inability to comply with the trial protocol
* Patients with a history of other malignancy ≤ 3 years prior to registration with the exceptions of a) cone-biopsied in situ carcinoma of the cervix uteri; b) basal or squamous cell carcinoma of the skin.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02127151
Study Brief:
Protocol Section:
NCT02127151