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Brief Title: Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
Official Title: A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
Study ID: NCT05997017
Brief Summary: A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
Detailed Description: This is a prospective phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma who have received 0-1 prior lines of chemotherapy in the recurrent/metastatic setting. Patients will be treated with nab-sirolimus (given IV on Days 1 and 8 in a 21-day cycle, combined with letrozole (orally, daily) until unacceptable toxicity or disease progression, or until in the opinion of the Investigator the patient is no longer benefiting from therapy, or at patient discretion.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Michael Birrer, MD, PhD, Little Rock, Arkansas, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Oklahoma University Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Women & Infants Hospital, Providence, Rhode Island, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Name: Willis Navarro, MD
Affiliation: Aadi Bioscience
Role: STUDY_DIRECTOR