A Phase I Study of Oral LEE011 in Patients with Advanced Solid Tumors or Lymphomas

Full Title

A Phase 1 Multicenter, Open Label, Dose-escalation Study of Oral LEE011 in Patients with Advanced Solid Tumors or Lymphomas


The primary purpose of this study is to find the highest dose of the investigational drug LEE011 that can be safely given to patients with advanced solid tumors or lymphoma, and to learn about the side effects that might occur following treatment. The study may also indicate how the drug works in cancer patients, and if possible, how effective it might be in treating certain types of cancer. LEE011 is taken orally (by mouth).

LEE011 blocks the activity of two enzymes called cyclin D kinases 4 and 6 (CDK4/6). These enzymes are part of a pathway known to regulate cell growth. Blocking the activity of CDK 4/6 prevents some cancer cells from being able to make a new copy of their DNA. As a result, they cannot divide and may enter into a process called programmed cell death. Researchers hope LEE011 will slow the growth of cancer cells and lead to their death.


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

  • Patients must have a confirmed diagnosis of an advanced solid tumor or lymphoma for which no further standard treatment options are available.
  • In order for LEE011 to inhibit CDK4/6, a protein called pRb must be present. Patients’ tumors must therefore test positive for the pRb protein.
  • At least 2 weeks must have passed since completing prior chemotherapy (4 weeks for biologic therapies) and entry into the study.
  • 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.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. John Gerecitano at 212-639-3748.