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Study of LY573636-Sodium in Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified by Eli Lilly and Company, December 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00718159
  Purpose

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
Acute Myeloid Leukemia
Drug: LY573636-sodium
Phase I

MedlinePlus related topics: Dietary Sodium Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Determine recommended Phase 2 dose of LY573636-sodium in patients with relapsed or refractory acute myeloid leukemia [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate pharmacokinetic (PK) parameters of LY573636-sodium [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Explore pharmacodynamic (PD) biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Estimate response rate by bone marrow response [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
  • Safety and tolerability of LY573636-sodium in patients with relapsed or refractory AML [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to at least one prior standard treatment. If patients have acute promyelocytic leukemia, they must be refractory to all trans retinoic acid (ATRA) and arsenic trioxide.
  • Are at least 18 years of age.
  • Have given written informed consent approved by Lilly and the ethical review board (ERB)/institutional review board (IRB) governing the site.
  • Must have adequate hepatic and renal function.
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days prior to study enrollment and recovered from the acute effects of therapy. Hydroxyurea used to control peripheral blood blast count is permitted within this 30-day period, but must be stopped at least 72 hours before study drug administration.
  • Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug.
  • Females of child bearing potential must have had a negative serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.

Exclusion Criteria:

  • Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
  • Patients with chronic myeloid leukemia (CML)
  • Have received an autologous or allogenic stem cell transplant within 90 days of the initial dose of study drug.
  • Have previously completed or withdrawn from this study or any other study investigating LY573636 sodium.
  • Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
  • Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study.
  • Have a known coagulopathy or bleeding disorder, other than leukemic related thrombocytopenia. Patients with severe or life-threatening bleeding refractory to platelet transfusions are also excluded from this study.
  • Major surgery within 4 weeks of study enrollment.
  • Are receiving warfarin (Coumadin).
  • Females who are pregnant or breast feeding.
  • Have known positive results of HIV, hepatitis B or C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718159

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
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            
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

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

Keywords provided by Eli Lilly and Company:
Acute Myeloid Leukemia
Myeloid Leukemia
Relapsed
Refractory

Study placed in the following topic categories:
Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009