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A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- Histologically confirmed recurrent or persistent endometrial carcinoma, which is
refractory to curative therapy or established treatments.

- All patients must have measurable disease as defined by RECIST 1.1. Measurable
disease is defined as at least one lesion that can be accurately measured in at least
one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm
when measured by CT, MRI or caliper measurement by clinical exam; or at least 20 mm
when measured by chest x-ray. Lymph nodes must be at least 15 mm in short axis when
measured by CT or MRI.

- Patients must have had at least one prior chemotherapeutic regimen for management of
endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and
radiation therapy, and/or consolidation/maintenance therapy.

- Patients must have not received any class of drugs targeted to the PI3K pathway
(including mTOR inhibitors) for management of recurrent or persistent disease.

- 18 years of age or greater

- Life expectancy of greater than 6 months

- ECOG performance status of 0, 1 or 2

- Normal organ and marrow function as outlined in the protocol

- Availability of formalin fixed paraffin embedded block of cancer tissue from the
original or most recent biopsy for mutational analysis

- Women of childbearing potential must use two forms of contraception prior to study
entry and for the duration of study participation.

- Toxicities of prior therapy (excepting alopecia) should be resolved to grade 1 or
lower per CTCAE version 4.

- Subjects with treated limited-stage basal cell or squamous cell carcinoma of the skin
or carcinoma in situ of the breast or cervix are eligible. Subjects with stage I or
II cancer treated with curative intent with no evidence of recurrent disease 5 years
following diagnosis are eligible.

- Patients must be able to tolerate oral medications and not have gastrointestinal
illnesses that would preclude absorption of MK-2206

Exclusion Criteria:

- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered to Grade 1 or less from adverse events due to agents administered more than
4 weeks earlier.

- Participants may not be receiving any other study agents

- Participants with known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to MK-2206

- Patients who require medications or substances that are strong inhibitors of inducers
of CYP 450 3A4

- Patients with diabetes or in risk of hyperglycemia should not be excluded, but the
hyperglycemia should be well controlled on oral agents before the patient enters the

- Baseline QTcF > 470msec

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant or breastfeeding women

- Patients who are unable to tolerate oral medication. Patients with signs and
symptoms of bowel obstruction or with uncontrolled, persistent diarrhea.

- HIV-positive individuals on combination antiretroviral therapy

- Patients may not use any natural herbal products or other "folk remedies" while on

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Andrea Myers, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • PIK3CA mutation
  • PIK3CA wildtype
  • MK-2206
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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