Amonafide in Combination With Cytarabine in Secondary AML
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|ClinicalTrials.gov Identifier: NCT00273884|
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : February 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Amonafide L-Malate Drug: Cytarabine||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Open-Label Study of Amonafide L-Malate in Combination With Cytarabine in Subjects With Secondary Acute Myeloid Leukemia (AML)|
|Study Start Date :||August 2005|
|Study Completion Date :||April 2009|
- - To determine the rate of complete remission with or without complete hematopoietic recovery (CR + CRi).
- Determine the median duration of complete remission with or without complete hematopoietic recovery (CR or CRi)
- Determine the proportion of subjects remaining in complete remission (CR +CRi) at 6 months, at 12 months and at 18 months
- Determine the median duration of overall survival (OS)
- Correlate clinical responses and duration of responses with specific cytogenetic abnormalities
- Define the population pharmacokinetic (PK) profile of amonafide and its metabolites when administered as an intravenous infusion daily x 5 days in combination with a standard-dose of cytarabine
- Define the safety profile and confirm the acceptability of amonafide and cytarabine
- Correlate PK exposure of amonafide and acetylation of amonafide with safety and efficacy assessments in individual subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273884
Show 21 Study Locations
|Principal Investigator:||Steven Allen, MD||North Shore Hospital|