Full Text View
Tabular View
Contacts and Locations
No Study Results Posted
Related Studies
A Study of LY2181308 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified by Eli Lilly and Company, July 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00620321
  Purpose

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

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To establish the proof-of-concept of survivin knockdown in AML blast cells. [ Time Frame: Baseline, during treatment, and follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Explore the activity/efficacy of LY2181308 sodium in relapsed or refractory AML. [ Time Frame: Baseline to progression ] [ Designated as safety issue: No ]
  • Assess the safety of LY2181308 sodium [ Time Frame: Baseline, during study and follow up visit ] [ Designated as safety issue: Yes ]
  • Refine the current LY2181308 sodium PK/PD model and to explore other potential PK/PD relationships. [ Time Frame: Baseline, during study and follow up visit ] [ Designated as safety issue: No ]
  • Explore consequences of survivin target knockdown on AML blast proliferation and blast survival. [ Time Frame: Baseline, during study and follow up visit ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]

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.


  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 standard treatment. A baseline bone marrow assessment is required less than or equal to 72 hours prior to the first dose of study drug.
  • Must have greater than or equal to 5% blasts present in peripheral blood at pre-study baseline assessment.
  • AML blast cells must express survivin.
  • Must have discontinued all previous therapies for cancer at least 30 days (6 weeks for mitomycin-C or nitrosoureas)before study enrollment. Hydroxyurea must be stopped at least 72 hours before study drug administration.
  • Must have adequate organ function.
  • Females must have a negative pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval.
  • Patients with acute promyelocytic leukemia (APML).
  • Patients with chronic myeloid leukemia (CML) in blast crisis.
  • Major surgery within 4 weeks of study enrollment.
  • Patients with serious pre-existing medical conditions.
  • Patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. Patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
  • Concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
  • Women who are pregnant or breast feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620321

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, 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            
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 9 AM - 5 PM Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 12, 2009