Study on Azenosertib for Treating Uterine Serous Carcinoma

Sponsor: Joyce Liu, MD

Sponsor score: 0

ClinicalTrials ID:NCT06369155

Provider View

This clinical trial is exploring how a new drug, Azenosertib, affects tumor cells in patients with persistent or returning uterine serous carcinoma. The study aims to understand the drug's impact on cancer growth.

Patient Parameters

Program Overview

The purpose of this study is to investigate how Azenosertib, a drug not yet approved by the FDA for uterine serous carcinoma, affects cancer cells in patients whose cancer has returned or persisted. Azenosertib has shown promise in stopping cancer cell growth in other diseases. Participants will undergo various tests and scans, including X-rays, CT scans, MRI scans, and blood tests, to monitor the effects of the treatment. About 25 people are expected to participate in this study, which is supported by Zentalis Pharmaceuticals.

Description

This study is testing Azenosertib, a drug that may help stop the growth of cancer cells in patients with persistent or returning uterine serous carcinoma. Although Azenosertib is not yet approved for this type of cancer, it has shown potential in other conditions. Participants will be screened for eligibility and will undergo various medical tests, including imaging scans and blood tests, to monitor their response to the treatment. The study involves regular visits for treatment and assessments. Zentalis Pharmaceuticals is providing the study drug for this research.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of recurrent or persistent uterine serous carcinoma.
  • Must have measurable disease, meaning at least one tumor that can be accurately measured.
  • Must have had at least one prior platinum-based chemotherapy treatment for advanced or metastatic uterine serous carcinoma.
  • Must be 18 years or older.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must have adequate organ and bone marrow function based on specific blood test results.
  • Must be willing to provide a tumor sample for research purposes.
  • Must have a tumor that can be biopsied and be willing to undergo biopsies before and during treatment.
  • HIV-positive participants must have an undetectable viral load and not be on certain medications that interact with Azenosertib.
  • Participants with treated brain metastases are eligible if their condition is stable.
  • Must agree to use effective contraception during the study and for a specified period after the last dose of the study drug.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Cannot have had chemotherapy, radiotherapy, or investigational therapy within 3 weeks before starting Azenosertib.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot be receiving other investigational treatments for this condition.
  • Cannot have previously received certain types of cancer treatments that affect cell cycle checkpoints.
  • Cannot have allergies to similar drugs as Azenosertib.
  • Cannot be taking medications that strongly interact with Azenosertib.
  • Pregnant or breastfeeding women are excluded due to potential risks to the baby.
  • Cannot have had major surgery within 28 days or minor surgery within 7 days before starting the study treatment.
  • Must be able to swallow oral medication and not have severe nausea or require certain types of nutritional support.
  • Cannot use herbal supplements during the study.
  • Must not have severe heart disease or a history of treatment with heart-damaging drugs.

Locations

FACILITYZIPCITYSTATE
Brigham and Women's Hospital02215BostonMassachusetts
Dana-Farber Cancer Institute02215BostonMassachusetts

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