A Phase II Study of MK-2206 for Recurrent Malignant Glioma
- Participants will have the following tests and procedures within 2 days before the
first dose of MK-2206: medical history, physical examination, blood tests, urine tests
- Participants in Part 2 of this research study may also have optional FDG-PET imaging
done. If the participant agrees, they will have two PET scans performed; one within a
week before beginning study drug, and another within 3 days after starting study drug.
- Participants in Part 1 will take MK-2206 orally prior to surgery on days 1-8 (with
surgery after the MK-2206 dose on day 8). They will have an EKG within 4-8 hours after
their first dose of MK-2206, and again on Day 8. During surgery, a sample of the tumor
will be taken for research. The tumor tissue will be analyzed to measure the level of
MK-2206 in the tumor and to study the effect of the drug on the tumor. Genetic tests
will be done on the tumor tissue to determine if the tumor's genetic profile can
predict response to treatment. You will also have 3 teaspoons of blood drawn to measure
the level of MK-2206 in the blood. An assessment of the participant's tumor by MRI or
CT scan will be done within 96 hours of surgery to determine how much of the tumor has
been removed. One to 4 weeks after surgery (within 14 days of the last MRI/CT scan),
MK-2206 treatment will restart at the same schedule as before surgery (weekly dosing).
Within 2 days prior to restarting MK-2206 the following tests and procedures must be
completed: medical history, physical examination, blood tests, urine test and EKG.
- Participants in both groups will receive MK-2206 by mouth once a week (Days 1, 8, 15,
and 22). Participants will receive an EKG within 4-8 hours after their first dose of
MK-2206 (for Part 1 participants, this is day 1 pre-surgery; for Part 2 participants,
this is day 1 of the first cycle of treatment). Participants will receive an EKG
weekly during their first cycle of treatment with MK-2206. The following tests and
procedures are required within 2 days before the start of each subsequent 4-week cycle
of MK-2206 treatment: medical history, physical examination, blood tests, urine test,
and EKG. Each treatment cycle lasts 4 weeks during which time participants will be
taking the study drug once a week. In addition, patients will also need the following
tests/procedures performed during treatment cycles: medical history and physical
examination on Day 15 (+/- 2 days) of Cycles 1 and 2 and blood tests weekly during
Cycle 1 and on Day 15 (+/- 2 days) of cycle 2.
- Assessments of the tumor by MRI will be performed within one week prior to the start of
each odd-numbered cycle, starting with cycle 3.
- Participants can continue to receive study drug until their disease worsens or develop
unacceptable side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Part 1: Akt inhibition
Quantitative pAkt analysis on post-treatment frozen tumor tissue. Equal or more than half of the specimens must demonstrate an absolute pAkt level that is consistent with adequated pAkt inhibition; this threshold has been determined by Merck based on data from prior phase I solid tumor re-biopsy studies.
Patrick Y. Wen, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|UCLA Medical Center||Los Angeles, California 90095-7059|
|Memorial Sloan Kettering||New York, New York 10021|