CLINICAL TRIALS PROFILE FOR AMONAFIDE

Clinical Trials for Amonafide

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00074100 ↗	Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 2	RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.
NCT00074100 ↗	Amonafide in Treating Women With Metastatic Breast Cancer That Has Progressed After Previous Chemotherapy	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	RATIONALE: Drugs used in chemotherapy, such as amonafide, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of amonafide in treating women who have metastatic breast cancer that has progressed after previous chemotherapy.
NCT00087854 ↗	Study of Individualized Amonafide to Treat Prostate Cancer	Completed	Xanthus Pharmaceuticals, Inc.	Phase 1/Phase 2	The purpose of this study is to assess the safety and efficacy of Amonafide in men with androgen-independent prostate cancer, assigned to individualized doses of Amonafide based on acetylator phenotype information (doses adjusted on individual metabolism).
NCT00273884 ↗	Amonafide in Combination With Cytarabine in Secondary AML	Completed	Xanthus Pharmaceuticals, Inc.	Phase 2	This protocol is designed to assess the safety and efficacy of amonafide in combination with cytarabine in subjects with previously untreated secondary AML.
NCT00715637 ↗	Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study	Unknown status	Antisoma Research	Phase 3	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. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.
NCT01066494 ↗	A Pharmacokinetic and Efficacy Study of Amonafide L-malate (AS1413) in Combination With Cytarabine in Patients With Acute Myeloid Leukemia (AML)	Unknown status	Antisoma Research	Phase 2	A phase IIa study to evaluate the pharmacokinetic and efficacy of amonafide L-malate (AS1413) in combination with cytarabine in treating patients with acute myeloid leukemia (AML)

Clinical Trial Conditions for Amonafide

Condition Name

Condition Name
Intervention	Trials
Acute Myeloid Leukemia	2
Prostate Cancer	1
Secondary Acute Myeloid Leukemia (Secondary AML, sAML)	1
Breast Cancer	1

Condition MeSH

Condition MeSH
Intervention	Trials
Leukemia	3
Leukemia, Myeloid, Acute	3
Leukemia, Myeloid	3
Prostatic Neoplasms	1

Clinical Trial Locations for Amonafide

Trials by Country

Trials by Country
Location	Trials
United States	42
Australia	5
Canada	4
United Kingdom	2
Russian Federation	2

Trials by US State

Trials by US State
Location	Trials
New York	4
California	3
South Carolina	2
North Carolina	2
Michigan	2

Clinical Trial Progress for Amonafide

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	3
Unknown status	2

Clinical Trial Sponsors for Amonafide

Sponsor Name

Sponsor Name
Sponsor	Trials
Xanthus Pharmaceuticals, Inc.	2
Antisoma Research	2
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	4
NIH	1
Other	1