PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
| Status: | Archived |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2011 |
A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
MK-2206 is a drug that may stop cancer cells from growing. MK-2206 blocks a signal inside
the cell that can cause abnormal cell growth. This drug has been used in other research
studies and information from those studies suggests that this agent may help to keep cancer
from growing in this research study. The investigators are looking to see how effective
MK-2206 is in treating recurrent and metastatic endometrial cancer. Additionally, the
investigators are looking to see if participants whose tumors contain a particular genetic
make-up will have a better response to MK-2206. Participants' tumors will be tested for a
mutation in a gene called PIK3CA, which makes a protein that helps cell to use energy and
grow.
- 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.
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