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

NCT05320757 | Completed Early Phase 1

• 1 other identifier: UW 21-521
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a window study where treatment-naïve patients will receive olaparib before definitive treatment. The aim is to evaluate the DNA damage and inflammatory response after PARP inhibitor.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer, olaparib

Outcome Measures

Primary Outcomes (1)

• Extent of DNA damage

  change of gH2Ax expression in tumor tissues in high-risk EC patients before and after olaparib as assessed by immunofluorescent staining (% change)

  Up to 18 months

Secondary Outcomes (2)

• Change of CD4 and CD8 T cells in tumor

  Up to 18 months

• Change of interferon gamma level in blood

  Up to 18 months

Study Arms (1)

Olaparib

EXPERIMENTAL

Olaparib: 300mg BID orally for 10 - 28 days (stop 3 - 4 days before definitive treatment)

Drug: Olaparib

Interventions

Olaparib DRUG

a PARP inhibitor

Also known as: Lynparza

Olaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with other malignancy unless curatively treated with no evidence of disease for \>= 5 years, are excluded.
• Patients whose resting ECG indicating uncontrolled, potentially reversible cardiac conditions, or patients with congenital long QT syndrome, are excluded.
• 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 with symptomatic uncontrolled brain metastases 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.
• \. 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.
• \. Patients with a known hypersensitivity to olaparib or any of the excipients of the product 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.
• \. 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ka Yu Tse

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: April 11, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)