Actively Recruiting
Azenosertib in Uterine Serous Carcinoma: Biomarker Study
Led by Joyce Liu, MD · Updated on 2026-03-02
25
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
Sponsors
J
Joyce Liu, MD
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma. The name of the study drug involved in this study is: -Azenosertib (a type of Wee1 inhibitor)
CONDITIONS
Official Title
Azenosertib in Uterine Serous Carcinoma: Biomarker Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed recurrent or persistent uterine serous carcinoma including uterine carcinomas with any serous component
- Measurable disease with at least one lesion measurable by RECIST 1.1 criteria
- Prior treatment with one platinum-based chemotherapy regimen for advanced or metastatic uterine serous carcinoma or recurrence within 12 months after adjuvant therapy
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function including neutrophil count 61500/mcL, hemoglobin 69 g/dL, platelets 6100,000/mcL, and acceptable liver and kidney function
- Willingness to provide archival tissue samples for research
- Biopsiable disease not used as target lesion and willingness to undergo biopsies
- HIV positive participants on effective treatment with undetectable viral load are eligible if not on strong CYP3A4 inhibitors or inducers
- Participants with treated brain metastases with no progression or with stable brain metastases not requiring immediate treatment
- Prior or concurrent malignancies allowed if not interfering with study safety or efficacy
- Use of effective contraception for women of childbearing potential and men
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy, radiotherapy, or investigational therapy within 3 weeks prior to study drug; 6 weeks for nitrosoureas or mitomycin C
- Hormonal therapy within 2 weeks prior to study drug
- Unresolved adverse effects from prior cancer therapy greater than Grade 1 except alopecia
- Use of other investigational agents for this condition
- Prior treatment with cell cycle checkpoint inhibitors such as Chek1, Wee1, or ATR inhibitors
- Allergic reactions to compounds similar to Azenosertib
- Use of strong CYP3A4 inhibitors or inducers
- Pregnant or breastfeeding women; women of childbearing potential not using contraception
- Major surgery within 28 days or minor surgery within 7 days before starting treatment (except Port-a-cath placement)
- Inability to swallow oral medication or presence of severe nausea, vomiting, PEG tube, TPN, or IV fluid dependence
- Use of herbal supplements within 7 days before study drug
- History or symptoms of significant cardiac disease with NYHA class worse than 2B
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Joyce Liu, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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