A Phase I Trial of Escalating Dose of RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
- This is a dose-escalation study in which 3 participants will be given a particular
starting dose of RAD001 on a certain schedule. If the dose and schedule are well
tolerated, then the next 3 participants enrolled will be assigned a new dosing schedule
and/or a higher dose of RAD001. This will continue until a maximum tolerated dose
(MTD) is reached for RAD001.
- Each cycle of treatment consists of 28 days on an outpatient basis. Participants will
receive RAD001 as the assigned schedule and dosage on day 1 and on days 8 through 28
for the first cycle. For all subsequent cycles RAD001 will be taken once daily.
Additionally, all participants will take PKC412 twice a day on days 2 through 28 for
the first cycle. For all subsequent cycles PKC412 will be taken twice daily.
- During the course of the trial the following evaluations and procedures will be
completed at various times: review of medical history; review of concomitant
medications; physical exam; performance status; vital signs; EKG; chest x-ray; blood
tests and bone marrow aspirate/biopsy.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To identify the maximum tolerated dose of RAD001 that can be given in combination with twice daily PKC412 in patients who are non-chemotherapy candidates with AML or MDS.
Richard Stone, 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|