A Phase II Study of Oral LEE011 and Everolimus in Patients with Persistent or Recurrent Neuroendocrine Tumors

Full Title

A Phase II Trial of LEE011 in Combination with Everolimus in the Treatment of Advanced well Differentiated Neuroendocrine Tumors of Foregut Origin

Purpose

The purpose of this study is to assess the safety and effectiveness of the combination of LEE011 and everolimus in patients with neuroendocrine tumors that continue to grow or have come back despite treatment. LEE011 is an investigational drug that blocks a protein called CDK, which tells some cancer cells to divide.

Everolimus is already used to treat neuroendocrine tumors, but it is being used at a lower dose in this study because it is being given in combination with LEE011. It works by inhibiting a molecule called mTOR, which helps cancer cells grow. Both LEE011 and everolimus are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a neuroendocrine tumor (thymic, lung, stomach, intestinal, or pancreatic) that has come back or continued to grow despite prior treatment.
  • At least 2 weeks must have passed since prior chemotherapy or targeted therapy and 4 weeks since radiation therapy and entry into the study.
  • Patients may not have previously received inhibitors of mTOR or CDK.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Diane Reidy-Lagunes at 646-888-4185.

Protocol

16-1535

Phase

II

Investigator

Co-Investigators