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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 determine whether LY2181308 sodium can decrease survivin protein in AML blast cells and to document any clinical efficacy in patients with relapsed or refractory acute myeloid leukemia. This study will also provide safety information of LY2181308 sodium and any side effects that may be associated with it.
Condition | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: LY2181308 sodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label Phase 2 Trial of LY2181308 Sodium Administered to Patients With Refractory or Relapsed Acute Myeloid Leukemia |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
LY2181308 sodium
|
Drug: LY2181308 sodium
LY2181308 750 mg is administered as a 3 hour intravenous (IV) infusion on Days 1, 2, 3 of Cycle 1 and Day 1 of Cycle 2. If patient does not experience disease progression or unacceptable toxicity in Cycles 1-2, the patient may start weekly dosing on Day 1 of Cycle 3 until disease progression or unacceptable toxicity develops. Cycles are 7 days in length. |
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. | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Eli Lilly | |
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, 48109 | |
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 | |
United States, Wisconsin | |
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 |
Madison, Wisconsin, United States, 53792 | |
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: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00620321 |
Health Authority: | United States: Food and Drug Administration |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |