Clinical Trials

A Phase II Study of MK-2206 in Patients with Recurrent or Advanced Endometrial Cancer Stratified by PIK3CA Mutation Status

Protocol
11-071
Full Title
A Phase II, 2-stage, 2-arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer (NCI #8760)
Purpose

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called MK-2206 in women with endometrial cancer that has returned or progressed despite prior treatment. Patients will be divided into two groups: those whose tumors contain a mutation in a gene called PIK3CA, and those without this mutation. This gene is involved in the AKT pathway.

MK-2206 works by turning off a protein called AKT. When AKT is turned on, signals are sent inside a cell that can cause abnormal cells to grow and divide faster; MK-2206 attempts to block these signals by turning off AKT. MK-2206 is a capsule that is taken orally (by mouth).

Investigator
Vicky Makker, MD
Vicky Makker - Physician Profile
Co-Investigators
Carol Aghajanian, MD -- Chief, Gynecologic Medical Oncology Service
Carol Aghajanian - Physician Profile
Eligibility

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 endometrial cancer that has returned or progressed despite prior treatment with at least one but no more than two regimens of chemotherapy.
  • At least 3 weeks must have passed since the completion of prior treatment and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 212-639-8596.

Disease(s)
Endometrial and other Uterine Cancers: Endometrial Cancer
Locations