Last updated on June 2019

Study of Ribociclib (LEE011) Everolimus and Letrozole in Patients With Advanced or Recurrent Endometrial Carcinoma


Brief description of study

The goal of this clinical research study is to learn if the combination of everolimus, letrozole, and ribociclib can help to control recurrent (has returned after treatment) or progressive endometrial cancer. The safety of this drug combination will also be studied.

This is an investigational study. Everolimus is FDA approved and commercially available to treat kidney, breast, and pancreatic cancers. Letrozole is FDA approved and commercially available to treat breast cancer and ovarian cancer. Ribociclib is not FDA approved or commercially available. It is currently being used for research purposes only. The combination of everolimus, letrozole, and ribociclib to treat endometrial cancer is investigational.

Up to 92 patients will have screening tests to learn if they are eligible to take part in this study. Up to 76 patients that are found eligible will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

Study Drug Administration:

Each study cycle is 28 days.

Participant will take everolimus, letrozole and ribociclib by mouth and should be swallowed whole without opening, chewing, or crushing 1 time every day at the same time. Participant will take the dose in the morning with a full cup of water (about 8 ounces). Participant should fast (not eat or drink anything except water) for up to 2 hours before and after each dose of study drugs.

When participant comes to clinic for a visit, participant should wait to take participant's drugs until the study team tells participant to take them.

Length of Treatment:

Participant may continue taking the study drugs for as long as the doctor thinks it is in participant's best interest. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after follow-up.

Study Visits:

On Day 1 of Each Cycle:

  • Participant will have a physical exam.
  • Blood (about 2 tablespoons) and urine will be collected for routine tests.
  • If the doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to check for hepatitis. If participant has had the hepatitis screening test during screening, it will not be repeated.
  • On Day 1 of Cycles 2 and beyond, participant will have an EKG.
  • On Day 1 of Cycle 3 and every 3 cycles after that (Cycles 6, 9, 12, and so on), part of the routine blood draw will be used to check the level of fat in participant's blood.

On Day 15 of Cycle 1:

  • Blood (about 3 tablespoons) will be drawn for routine and pharmacodynamic PD testing.
  • Participant will have three EKGs 5 minutes apart before the dose and then 2-4 hours after.

On Day 15 of Cycle 2, participant will have an EKG before and then 2-4 hours after the dose.

At the end of Cycles 2, 4, 6 and every 3 cycles after that (Cycles 9, 12, 15, and so on) (+/- 7 days):

  • Participant will have an MRI and/or CT scan. If participant has signs of disease in the chest chest disease, participant will have a CT scan of the chest.
  • If the disease could be felt in the pelvis at the beginning of the study, participant will have a pelvic exam.

End-of-Treatment Visit:

Within 4 weeks after the last dose of study drugs:

  • Participant will have a physical exam.
  • Blood (about 2 tablespoons) and urine will be collected for routine tests.
  • Participant will have an MRI and/or CT scan. If participant has signs of disease in the chest, participant will have a CT scan of the chest.

Follow-Up:

At 30 days after participant's last dose of study drugs and then every 3 months (+/- 1 month) after that, a member of the study staff will contact participant by phone or at a regularly scheduled clinic visit to ask how participant is doing and about any side effects participant may have had. These calls or visits should last about 5-10 minutes each time.

Clinical Study Identifier: NCT03008408

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