Study on AZD1775 for Women with Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT03668340

Provider View

This clinical trial is testing an investigational drug called AZD1775 to see if it can help treat uterine cancer that has come back or is not going away. The study aims to find out if AZD1775 is safe and effective for this type of cancer.

Patient Parameters

Program Overview

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new drug, AZD1775, to see if it works for treating uterine cancer. AZD1775 is not yet approved by the FDA for any disease. It is being tested alone in patients with this type of cancer and is also being studied in other cancers like lung and ovarian cancer. AZD1775 works by blocking a protein called Wee1, which helps control how cells grow and divide. Some cancer cells might be more affected by this blockage, and the study aims to see if AZD1775 can help treat uterine cancer.

Description

This study is testing a new drug called AZD1775 to see if it can help treat uterine cancer that has come back or is not going away. AZD1775 is not yet approved by the FDA and is considered investigational, meaning it is still being studied. The drug is being given alone to patients with this type of cancer. It works by blocking a protein called Wee1, which helps control how cells grow and divide. Some cancer cells might be more affected by this blockage, and the study aims to see if AZD1775 can help treat uterine cancer. The study will also look at the safety of the drug and how well it works in shrinking tumors.

Eligibility Criteria

Inclusion Criteria

  • Women with confirmed recurrent or persistent uterine serous carcinoma or uterine carcinosarcoma.
  • Must have a specific genetic change called p53 alteration for certain parts of the study.
  • Cancer must be measurable by scans.
  • Must have had at least one prior chemotherapy treatment for advanced or metastatic cancer.
  • Age 18 or older.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have normal organ and blood function based on specific tests.
  • Must be willing to provide a tissue sample for research.
  • Must agree to use effective birth control during the study and for one month after.
  • Must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
  • Must be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Recent chemotherapy, radiotherapy, or investigational therapy within 3 weeks before starting AZD1775.
  • Currently taking other investigational drugs.
  • Tumors with specific genetic features unless previously treated with certain immune therapies.
  • Known brain metastases or other central nervous system diseases unless treated and stable.
  • Allergic reactions to similar drugs.
  • Previous treatment with certain cell cycle inhibitors.
  • Taking medications that interact with AZD1775 and cannot be stopped.
  • Recent major surgery within 28 days or minor surgery within 7 days before starting the study.
  • Unable to swallow pills or dependent on IV nutrition.
  • Certain heart conditions or abnormal heart rhythms.
  • Other active cancers or serious health conditions.
  • Pregnant or breastfeeding women.
  • Known HIV-positive status due to potential drug interactions.
  • Use of herbal supplements during the study.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts

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