AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma (NCT03668340) | Clinical Trial Compass
Active — Not RecruitingPhase 2
AZD1775 in Women With Recurrent or Persistent Uterine Serous Carcinoma or Uterine Carcinosarcoma
United States49 participantsStarted 2018-10-22
Plain-language summary
This research study is studying an investigational drug as a possible treatment for uterine cancer.
The drug involved in this study is:
-AZD1775
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Participants in Parts A and C 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 component that is considered serous will be considered a uterine serous carcinoma.
* Participants in Part B must have histologically or cytologically confirmed recurrent uterine carcinosarcoma. Additionally, the following features must also be present:
* Presence of a p53 alteration (by either IHC or next generation sequencing)
* Metastatic or extra-uterine component must be confirmed on pathology to be from the carcinoma component of the disease
* Patients without confirmation that the metastatic or extrauterine component of disease is of carcinoma histology may be considered after discussion with the PI
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured per RECIST 1.1 criteria. See Section 11 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 or uterine carcinosarcoma. Chemotherapy administered only in conjunction with primary RT as a radiosensitizer should not count as a systemic regimen. There is no restriction on the number of prior lines of therapy a participant may have previously received.
* Age 18 years or older.
* ECOG…