Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273884
Status:
COMPLETED
Last Update Posted:
2007-02-19
First Post:
2006-01-05
Brief Title:
Amonafide in Combination With Cytarabine in Secondary AML
Sponsor:
Xanthus Pharmaceuticals Inc
Organization:
Xanthus Pharmaceuticals Inc
Study Overview
Official Title:
Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML
Detailed Description:
This is a two-stage open-label phase 2 multicenter study of amonafide L-malate in combination with standard-dose cytarabine in subjects with secondary AML
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors Amonafide has also been studied in patients with AML In three phase I clinical trials amonafide demonstrated anti-leukemic activity both as monotherapy and in combination with cytarabine This protocol is designed to further assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML
The duration of the study is approximately 42 months enrollment approximately 18 months and subject duration up to 24 months
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors Amonafide has also been studied in patients with AML In three phase I clinical trials amonafide demonstrated anti-leukemic activity both as monotherapy and in combination with cytarabine This protocol is designed to further assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML
The duration of the study is approximately 42 months enrollment approximately 18 months and subject duration up to 24 months
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