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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Percentage Change in Replication Fork Speed in Overall Response

Secondary study objectives

6-month Progression-Free Survival (PFS6)

Clinical Benefit Rate (CBR)

Grade 3-5 Treatment-related Toxicity Rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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