A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
Aadi Bioscience, Inc.
Summary
A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is suggested but not required. 2. All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging \[MRI\] if CT scans are contraindicated) as defined by RECIST version 1.1. 3. Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity. 4. Prior treatment history: 1. Adjuvant settin…
Interventions
- Drugnab-sirolimus
Prospective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients
Locations (9)
- Michael Birrer, MD, PhDLittle Rock, Arkansas
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- Women's Cancer Center of NevadaLas Vegas, Nevada
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Levine Cancer InstituteCharlotte, North Carolina
- Oklahoma University Stephenson Cancer CenterOklahoma City, Oklahoma