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A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified by Eli Lilly and Company, August 2009
First Received: February 4, 2008   Last Updated: August 20, 2009   History of Changes
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 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To understand the safety profile of LY2181308 sodium administered in combination with idarubicin and cytarabine through adverse events and serious adverse events [ Time Frame: during treatment and follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Explore the activity of LY2181308 sodium in combination with idarubicin and cytarabine using remission rates and relapse-free survival. [ Time Frame: Baseline to progression ] [ Designated as safety issue: No ]
  • Refine the current LY2181308 PK/PD model using the LY2181308 PK/PD (flow cytometry) data. [ Time Frame: baseline, during study, and follow up visit ] [ Designated as safety issue: No ]
  • Explore other potential PK/PD relationships (for example, with blast counts) [ 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 by fluorescence activated cell sorting (FACS) using cell cycle progression and apoptosis markers. [ Time Frame: Baseline, during study and follow up visit ] [ Designated as safety issue: No ]

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.

  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 a least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (CML) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (TK1). A baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.
  • Must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. Hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration. 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.
  • Patients must be at least 18 years old.

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
  • Patients with acute promyelocytic leukemia (APML).
  • Major surgery within 4 weeks of study enrollment.
  • Patients with serious pre-existing medical conditions (at the discretion of the investigator). Because of the known cardiac toxicity of anthra- cyclines, patients with pre-existing ejection fraction (EF) less than or equal to 45% should not participate in this study. No patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120mg/m2).
  • Patients with a second malignancy that could affect the interpretation of the results.
  • Patients with leukemic involvement of the CNS by spinal fluid cytology or imaging.
  • 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.
  • Patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
  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. 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            
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: August 20, 2009
ClinicalTrials.gov Identifier: NCT00620321     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Anti-Bacterial Agents
Anti-Infective Agents
Leukemia
Idarubicin
Acute Myelocytic Leukemia
Immunologic Factors
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Cytarabine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 04, 2009