Ignite Creation Date:
2025-12-17 @ 3:50 PM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT00762632
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2008-09-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia
Sponsor:
Technical University of Munich
Organization:
Study Overview
Official Title:
An Open-label Phase I/II (Proof of Concept) Trial of an Combination of Nilotinib (AMN 107) and RAD001 in Patients With Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2012-08
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:
This is a nonrandomized, open-label study to evaluate the efficacy and safety of combination treatment of Nilotinib and RAD001 in the treatment of c-kit + AML. Patients refractory to standard chemotherapy or not eligible to standard chemotherapy can be included. Patients will be treated with 400 mg Nilotinib bid (total daily dose 800 mg). RAD001 will be added after a treatment duration of 1 week in a dosage of 2,5 mg/day. Treatment duration will be 25 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: