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New treatment option for Uterine Serous Carcinoma
Official title Azenosertib in Uterine Serous Carcinoma: Biomarker Study
ClinicalTrials.gov ID: NCT06369155
What this study is testing
What is Azenosertib?
Azenosertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for uterine serous carcinoma.
Also referred to as Zn-c3, C29H34N8O2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participants must have histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma. For the purposes of this study...
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST 1.1 criteria. See Section 12 for...
- Participants must have had one prior platinum-based chemotherapy regimen for management of advanced or metastatic uterine serous carcinoma...
- Age 18 years or older. Because no dosing or adverse event data are currently available on the use of azenosertib in participants \<18 years of age...
- ECOG performance status 0, 1, or 2 (see Appendix A)
You likely can't join if
- Participants who have had chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy administered more than 3 weeks before first dose of...
- Participants who are receiving any other investigational agents for this condition.
- Participants may not have had prior receipt of a cell cycle checkpoint inhibitor (e.g., Chek1, Wee1, or ATR inhibition)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azenosertib.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these...
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed recurrent or persistent uterine serous carcinoma. For the purposes of this study, uterine carcinomas (with the exception of carcinosarcomas) that have any...
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST 1.1 criteria. See Section 12 for the evaluation of measurable disease.
- Participants must have had one prior platinum-based chemotherapy regimen for management of advanced or metastatic uterine serous carcinoma. Participants with early stage disease who received adjuvant platinum-based...
- Age 18 years or older. Because no dosing or adverse event data are currently available on the use of azenosertib in participants \<18 years of age, children are excluded from this study.
- ECOG performance status 0, 1, or 2 (see Appendix A)
- Participants must meet the following organ and marrow function as defined below:
- absolute neutrophil count ≥1500/mcL
- hemoglobin ≥9 g/dL (must be at least 2 weeks since any blood transfusion)
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN) or ≤1.5x ULN in patients with liver metastases or well-documented Gilbert's Syndrome
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN or ≤5 × institutional ULN in patients with liver metastases
- creatinine ≤ 1.5x institutional ULN or estimated CrCl≥ 60 mL/min
- Willingness to release archival tissue for research purposes.
- Biopsiable disease in a lesion that is not being utilized as the target lesion for RECIST assessment and willing to undergo pre- and on-treatment biopsies.
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. However, participants who are on antiretroviral therapy that includes strong...
- Participants with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Participants with new or progressive brain metastases (active brain...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- The effects of azenosertib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Participants who have had chemotherapy, radiotherapy, or investigational therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of azenosertib. Participants may not have had hormonal...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy administered more than 3 weeks before first dose of azenosertib (e.g.,., have residual toxicities \> Grade 1) with the exception...
- Participants who are receiving any other investigational agents for this condition.
- Participants may not have had prior receipt of a cell cycle checkpoint inhibitor (e.g., Chek1, Wee1, or ATR inhibition)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azenosertib.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a...
- Pregnant women are excluded from this study because azenosertib is an DNA damage repair pathway agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for...
- Participants must not have undergone major surgical procedures within 28 days of beginning study treatment or minor surgical procedures within 7 days of beginning study treatment. Port-a-cath placement will be allowed...
- Participants must be able to swallow oral medication and may not have refractory nausea and vomiting, have a percutaneous endoscopic gastrostomy (PEG) tube, be receiving total parenteral nutrition (TPN), or be dependent...
- Because the composition, PK, and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, cannabis, St. John's wort...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.