Finding studies
Finding studies
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Lead
Dana-Farber Cancer Institute
With
* 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 and EKG. * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
