A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
- Participants will take the study drug, MK-2206, orally once a week. Each treatment
cycle lasts four weeks (28 days). Participants will be asked to complete a drug diary
stating when they took each dose and to give a reason if they did not take the drug.
At the end of each cycle, participants will be asked to return the pill bottles and all
of the remaining pills before starting the next cycle.
- At the beginning of each cycle the following procedures and tests will be performed:
physical exam, evaluation of performance status, blood samples. Once a week for the
first two cycles the following procedures and tests will be performed: participant will
be called at home by a member of the study team to record any health problems,
including side effects from the study drugs and blood samples.
- A CT scan or MRI of the chest, stomach area, and pelvis will be performed every 2
cycles to see if the cancer is increasing, decreasing, or staying the same size.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the activity of MK-2206 in this patient population classified by PIK3CA mutation. Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response
Andrea Myers, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Memorial Sloan-Kettering||New York, New York|