Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030186
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2002-02-07
Brief Title:
Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
An Open-Label Study of CEP-701 in Patients With Refractory Relapsed or Poor Risk Acute Myeloid Leukemia Expressing FLT-3 Activating Mutations
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:
The purpose of this study is to determine the response rate of patients with refractory relapsed or poor risk AML expressing FLT-3 activating mutations when administered CEP-701 at a dosage of 60 mg 2 times a day
Detailed Description:
This is an open-label study of CEP-701 in patients with refractory relapsed or poor risk AML expressing FLT-3 activating mutations Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days 1 cycle Upon completion of cycle 1 the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day dependent upon response to 60 mg dosage
Study Oversight
Has Oversight DMC:
None
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?:
None