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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00620321 |
The purpose of this study is to understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine to patients with relapsed or refractory AML.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: LY2181308 sodium Drug: cytarabine Drug: idarubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label Phase 2 Trial of LY2181308 Sodium Administered in Combination With Idarubicin and Cytarabine to Patients With Refractory or Relapsed Acute Myeloid Leukemia |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
LY2181308 sodium, idarubicin, cytarabine: Experimental |
Drug: LY2181308 sodium
750 mg is administered as a 3 hour intravenous (IV) infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 of Cycle 2 until disease progression or unacceptable toxicity develops.
Drug: cytarabine
1.5g/m2 will be administered as a 4 hour IV infusion on Days 3, 4, 5 of Cycle 1 and Days 1, 2, 3 of Cycle 2 until disease progression or unacceptable toxicity develops.
Drug: idarubicin
12mg/m2 will be administered as a 30 minute IV infusion on Days 3, 4, 5 of Cycle 1 and on Days 1, 2, 3 of Cycle 2 until disease progression or unacceptable toxicity develops.
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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: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) | 1-317-615-4559 |
United States, Indiana | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Active, not recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, Michigan | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Ann Arbor, Michigan, United States, 48105 | |
Contact: Eli Lilly | |
United States, Texas | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Eli Lilly |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11631, H8Z-MC-JACU |
Study First Received: | February 4, 2008 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00620321 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Bacterial Agents Anti-Infective Agents Leukemia Idarubicin Acute Myelocytic Leukemia |
Immunologic Factors Leukemia, Myeloid Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid Antibiotics, Antineoplastic |
Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Idarubicin Therapeutic Uses Cytarabine |