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Wee1 inhibitor

Azenosertib for Uterine Cancer

Phase 2

Waitlist Available

Led By Joyce Liu, MD, MPH

Research Sponsored by Joyce Liu, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is looking at how a drug called Azenosertib affects tumor cells in a specific type of uterine cancer called uterine serous carcinoma that has come back or has not

Who is the study for?

This trial is for adults with persistent or recurrent uterine serous carcinoma who've had one prior platinum-based chemotherapy. They must have measurable disease, be able to consent, and agree to use contraception. Excluded are those allergic to similar compounds as Azenosertib, pregnant/breastfeeding women, and those on certain medications.Check my eligibility

What is being tested?

The study tests how Azenosertib (a Wee1 inhibitor) affects tumor cells in uterine serous carcinoma patients. Participants will take the drug orally and provide tissue samples before and during treatment for research purposes.See study design

What are the potential side effects?

Potential side effects of Azenosertib may include reactions similar to allergies experienced from related compounds. Specific side effects aren't listed but typically could involve nausea, fatigue, blood count changes or other common drug-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6)

Percentage Change in Replication Fork Speed in Overall Response

Secondary outcome measures

6-month Progression-Free Survival (PFS6)

Clinical Benefit Rate (CBR)

Grade 3-5 Treatment-related Toxicity Rate

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AzenosertibExperimental Treatment1 Intervention

25 participants will be enrolled and will complete study procedures as follows: Baseline visit with assessments and CT or MRI scan. CT or MRIs scans every 2 cycles. Cycle 1 through End of Treatment: --Days 1 through 5, 8 through 12, and 15 through 19: Predetermined dose of Azenosertib 1x daily. End of Treatment visit.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Joyce Liu, MDLead Sponsor

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,494 Total Patients Enrolled

ZentalisUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As per the details listed on clinicaltrials.gov, patient recruitment for this specific trial is presently inactive. The initial posting of this study dates back to September 1st, 2024, with the most recent revision made on April 12th, 2024. Despite its current closed status for enrollment, there are currently a total of 2628 ongoing trials actively seeking participants."

Answered by AI

Has Azenosertib received clearance from the FDA for clinical use?

"Our team at Power has assessed the safety of Azenosertib as a 2 on our scale due to this being a Phase 2 trial, signifying existing safety data but lacking efficacy evidence."

Answered by AI

What is the primary goal of conducting this clinical trial?

"The primary aim of this investigation, to be assessed at around the 6-month mark, is focused on determining the fluctuation in replication fork speed concerning overall response. Secondary goals encompass evaluating Median Progression-Free Survival (PFS), which delineates progression-free survival according to Kaplan-Meier methodology as the time span between randomization and confirmed disease progression or mortality unless data is incomplete; monitoring Grade 3-5 Treatment-related Toxicity Rate involving adverse events rated as grade 3-5 with potential links to treatment based on CTCAEv5 that persist despite adherence to therapeutic protocols; and examining Overall Response Rate (ORR) by calculating"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Azenosertib in Uterine Serous Carcinoma: Biomarker Study

Joyce Liu, MD 2024. "Azenosertib in Uterine Serous Carcinoma: Biomarker Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369155.

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