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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00718159 |
The purpose of this study is to determine a safe dose of LY573636-sodium to be given to patients with relapsed or refractory acute myeloid leukemia and to determine any side effects that may be associated with LY573636-sodium in this patient population. Efficacy measures will also be used to assess the activity of LY573636-sodium in this patient population.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: LY573636-sodium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Study of LY573636-Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia |
Estimated Enrollment: | 45 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: LY573636-sodium
This study uses a 3 + 3 dose escalation design based on targeted Cmax, with a cohort expansion at the maximum tolerated dose. A 24 hour IV infusion of LY573636-sodium is given on Day 1 of each 35 day cycle. Patients can continue treatment until they meet discontinuation criteria (eg. disease progression).
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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, California | |
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 |
La Jolla, California, United States, 92037 | |
Contact: Eli Lilly | |
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 |
Los Angeles, California, United States, 90095 | |
Contact: Eli Lilly | |
United States, Illinois | |
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 |
Chicago, Illinois, United States, 60611 | |
Contact: Eli Lilly | |
United States, Minnesota | |
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 |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Eli Lilly | |
United States, Tennessee | |
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 |
Nashville, Tennessee, United States, 37203 | |
Contact: Eli Lilly | |
United States, Washington | |
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 |
Seattle, Washington, United States, 98109 | |
Contact: Eli Lilly | |
Puerto Rico | |
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. | Not yet recruiting |
San Juan, Puerto Rico, 00935 | |
Contact: Eli Lilly |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon -Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 12266, H8K-MC-JZAJ |
Study First Received: | July 16, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00718159 |
Health Authority: | United States: Food and Drug Administration |
Acute Myeloid Leukemia Myeloid Leukemia Relapsed Refractory |
Leukemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Neoplasms Neoplasms by Histologic Type |