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Sponsored by: |
Antisoma Research |
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Information provided by: | Antisoma Research |
ClinicalTrials.gov Identifier: | NCT00715637 |
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.
Condition | Intervention | Phase |
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Secondary Acute Myeloid Leukemia (sAML) |
Drug: Daunorubicin and Cytarabine Drug: Amonafide and Cytarabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML) |
Estimated Enrollment: | 350 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Amonafide in Combination with Cytarabine
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Drug: Amonafide and Cytarabine
Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)
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Arm B: Active Comparator
Daunorubicin in Combination with Cytarabine
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Drug: Daunorubicin and Cytarabine
Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bill Lundberg, MD | 617-225-0522 ext 164 | bill.lundberg@antisoma.com |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States | |
Contact: Natalie Jeha 415-476-4126 njeha@medicine.ucsf.edu | |
Contact: Beth Davis 415-502-3176 bdavis@medicine.ucsf.edu | |
Principal Investigator: Lloyd Damon | |
UCLA Medical Center | Recruiting |
LA, California, United States, 90095 | |
Contact: Rose Malone 310-794-0244 rmalone@mednet.ucla.edu | |
Principal Investigator: Schiller Gary, MD | |
United States, Colorado | |
Rocky Mountain Blood and Marrow Transplant Program | Recruiting |
Denver, Colorado, United States | |
Contact: Juli Murphy 303-285-5087 Juli.Murphy@usoncology.com | |
Contact: Nicole Stephens 303-336-2183 Nicole.Stephens@usoncology.com | |
Principal Investigator: Michael Maris, MD | |
United States, Florida | |
M. D. Anderson Cancer Center Orlando | Recruiting |
Orlando, Florida, United States | |
Contact: Terra Warner 321-841-1907 Terra.warner@orhs.org | |
Principal Investigator: Jose E Sarriera, MD | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States | |
Contact: Richard M Stone, MD | |
Contact: Galinski Ilene, APRN-C | |
Principal Investigator: Richard M Stone, MD | |
United States, Michigan | |
University of Michigan Cancer Center | Recruiting |
Ann Arbor, Michigan, United States | |
Contact: Amanda Dressel 734-763-0005 adressel@umich.edu | |
Contact: Irene Ryan 734-647-9757 iryan@umich.edu | |
Principal Investigator: Harry Erba, MD | |
United States, New York | |
Northshore Hospital - Monter Cancer Center | Recruiting |
Lake Success, New York, United States | |
Contact: Vivian O'Mara 516-734-8940 VOMara@nshs.edu | |
Principal Investigator: Steve Allen, MD | |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States | |
Contact: Jennifer MacLean, BS, RN, OCN 336-713-3539 jemaclea@wfubmc.edu | |
Contact: Scarlett Hutchens, RN, BSN 336-713-6915 snhutche@wfubmc.edu | |
Principal Investigator: Bayard Powell, MD |
Responsible Party: | Antisoma ( J. Kris Piper, Senior VP Clinical Operations and Regulatory Affairs ) |
Study ID Numbers: | 509912 |
Study First Received: | July 14, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00715637 |
Health Authority: | United States: Food and Drug Administration |
AML Leukemia MDS Amonafide |
Cytarabine Daunorubicin Lymphatic disorders |
Daunorubicin Lymphatic Diseases Leukemia Acute myelogenous leukemia Neoplasm Metastasis |
Leukemia, Myeloid Amonafide Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses |