Ignite Creation Date:
2024-05-05 @ 9:06 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00819546
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2009-01-08
Brief Title:
RAD001 in Combination With PKC412 in Patients With Relapsed Refractory or Poor Prognosis AML or MDS
Sponsor:
Richard Stone MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Trial of Escalating Dose of RAD001 in Combination With PKC412 in Patients With Relapsed Refractory or Poor Prognosis AML or MDS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine the safety of the combination of RAD001 and PKC412 as a cancer treatment and to establish the highest dose of RAD001 that can be given in conjunction with PKC412 These drugs have been used in other research trials for individuals with solid and hematology malignancies Past research on PKC412 shows that it blocks the abnormal functioning of an enzyme called FLT3 FLT3 is found in your cells in either a normal wild type or genetically changed form and plays a role in the survival and growth of AML cells RAD001 is an inhibitor of a central growth pathway that involves the protein MTOR The MTOR pathway is overactive in cancer cells causing the cells to grow abnormally By inhibiting the abnormal growth activity of the MTOR pathway RAD001 slows down and possibly stops the growth of cancer cells
Detailed Description:
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 andor 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 aspiratebiopsy
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 aspiratebiopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None