Effects of PARP Inhibitor on Tumor Microenvironment in High-risk Endometrial Cancer Patients

Korábbi kezelés

• Patients with other malignancy unless curatively treated with no evidence of disease for >= 5 years, are excluded.
• Concomitant use of known strong CYP3A inhibitors or inducer are excluded. 10. Patients who have major surgery within 2 weeks, previous allogenic bone marrow transplant, are excluded.
• Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, proceeding the first dose of study drug is not allowed.

Más betegség

• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML, other hematological diseases such as venous or arterial thrombosis and thrombocytopenia are excluded.
• Patients who are unable to swallow orally administered medication and gastrointestinal disorders are excluded.
• Patients with immunocompromised condition, active hepatitis, or persistent toxicities caused by previous cancer therapy, are excluded.
• Patients with a known hypersensitivity to olaparib or any of the excipients of the product are excluded.

Laborértékek

• Patients whose resting ECG indicating uncontrolled, potentially reversible cardiac conditions, or patients with congenital long QT syndrome, are excluded.

Egyéb

• Patients with symptomatic uncontrolled brain metastases are excluded.
• Pregnant or breastfeeding women are excluded. 14. Patients who are judged by the investigator to be unlikely to comply with study procedures, restrictions and requirements are excluded.

• Patients must be capable of giving signed informed consent
• Patients must be at least 18 years old
• Patients must have newly diagnosed and histologically confirmed high-risk endometrial cancer, including:
  • G3 endometrioid, any stage
  • Type 2 (such as serous, clear cell, carcinosarcoma), any stage
  • G1 endometrioid, stage 2 or beyond
• The endometrial cancer should be visible on pre-treatment ultrasound, or endometrial lining should be 5mm or above
• An archived FFFE sample of endometrial biopsy or at least 8 unstained slides should be available
• Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
• Patients must have adequate bone marrow, renal, hepatic, thyroid and neurological function within 28 days prior to administration of study treatment
• Patients must be able to swallow oral medication
• Patients must have a life expectancy of ≥ 16 weeks
• Patients must either be postmenopausal or show evidence of non-childbearing status for women of childbearing potential