Effects of a drug on tumor environment in high-risk endometrial cancer patients

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

This study is testing if the drug olaparib can change the tumor environment in patients with high-risk endometrial cancer before they start their main treatment.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: The University of Hong Kong (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hong Kong)
• Trial ID: NCT05320757 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of the PARP inhibitor olaparib on the tumor microenvironment in patients with high-risk endometrial cancer. Treatment-naïve patients will receive olaparib prior to definitive treatment to assess DNA damage and inflammatory responses. The study aims to clarify how olaparib alters the immune landscape in both blood and tumor tissues. This early-phase trial is crucial for understanding the potential of targeted therapies in improving outcomes for patients with this aggressive cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed, histologically confirmed high-risk endometrial cancer.

Not a fit: Patients with low-risk endometrial cancer or those who are not treatment-naïve may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for high-risk endometrial cancer patients, potentially reducing recurrence rates.

How similar studies have performed: While there is emerging evidence supporting the use of PARP inhibitors in various cancers, the specific application in high-risk endometrial cancer is still being explored and may represent a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Patients must be capable of giving signed informed consent
2. Patients must be at least 18 years old
3. Patients must have newly diagnosed and histologically confirmed high-risk endometrial cancer, including:

   1. G3 endometrioid, any stage
   2. Type 2 (such as serous, clear cell, carcinosarcoma), any stage
   3. G1 endometrioid, stage 2 or beyond
4. The endometrial cancer should be visible on pre-treatment ultrasound, or endometrial lining should be 5mm or above
5. An archived FFFE sample of endometrial biopsy or at least 8 unstained slides should be available
6. Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1
7. Patients must have adequate bone marrow, renal, hepatic, thyroid and neurological function within 28 days prior to administration of study treatment
8. Patients must be able to swallow oral medication
9. Patients must have a life expectancy of ≥ 16 weeks
10. Patients must either be postmenopausal or show evidence of non-childbearing status for women of childbearing potential

Exclusion Criteria:

1. Patients with other malignancy unless curatively treated with no evidence of disease for \>= 5 years, are excluded.
2. Patients whose resting ECG indicating uncontrolled, potentially reversible cardiac conditions, or patients with congenital long QT syndrome, are excluded.
3. 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.
4. Patients with symptomatic uncontrolled brain metastases are excluded.
5. Patients who are unable to swallow orally administered medication and gastrointestinal disorders are excluded.
6. Patients with immunocompromised condition, active hepatitis, or persistent toxicities caused by previous cancer therapy, are excluded.

9. 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.

11. Patients with a known hypersensitivity to olaparib or any of the excipients of the product are excluded.

12. 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.

13. 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.

Where this trial is running

Hong Kong

• The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)

Study contacts

• Principal investigator: Ka Yu Tse — The University of Hong Kong
• Study coordinator: Lesley Lau

Conditions Endometrial Cancer; Endometrial cancer, olaparib