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A Study for Patients With Acute Leukemia

This study has been terminated.
(Primary objective has been met and in the absence of clinically meaningful remissions)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01214655
First Posted: October 5, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to patients with acute leukemia. Part A and Part B are dose escalation of two schedules in patients with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in patients with acute myeloblastic leukemia (AML).

Condition Intervention Phase
Acute Leukaemia Drug: LY2523355 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of LY2523355 in Patients With Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Recommended dose and schedule for Phase 2 studies in acute leukemia [ Time Frame: Baseline to study completion ]

Secondary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for both schedules ]
  • Response Rate for acute myelogenous leukemia using The Revised International Working Group Criteria [ Time Frame: Baseline to disease progression or discontinuation ]
  • Response rates for chronic myelogenous leukemia in blast crisis (complete hematologic response, no evidence of leukemia, return to chronic phase) [ Time Frame: Baseline to disease progression or discontinuation ]
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for both schedules ]
  • Response rate for acute lymphoblastic leukemia using The Revised International Working Group Criteria [ Time Frame: Baseline to disease progression or discontinuation ]

Enrollment: 33
Study Start Date: June 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2523355 1,2,3
Days 1,2 and 3. Starting dose is 2mg/m2.
Drug: LY2523355
Administered intravenously for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met.
Experimental: LY2523355 1,5,9
Days 1, 5 and 9. Starting dose is 8mg/m2.
Drug: LY2523355
Administered intravenously for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Dose escalation period for both schedules:

  • Patient must have a confirmed diagnosis of acute leukemia regardless of sub-type for whom experimental phase 1 therapy is appropriate
  • Are greater than or equal to 18 years of age
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug

Dose confirmation period for both schedules:

  • Participant must have a confirmed diagnosis of untreated AML, should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
  • Are greater than or equal to 60 years of age
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug

Exclusion Criteria:

  • Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
  • Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
  • Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry
  • Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
  • Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant
  • Have uncontrolled systemic infection
  • Females who are pregnant or lactating
  • Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214655


Locations
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.
Chicago, Illinois, United States
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.
Indianapolis, Indiana, United States
United States, Massachusetts
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.
Boston, Massachusetts, United States
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.
Nashville, Tennessee, United States
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.
Houston, Texas, United States
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214655     History of Changes
Other Study ID Numbers: 12119
I1Y-MC-JFBC ( Other Identifier: Eli Lilly and Company )
First Submitted: October 1, 2010
First Posted: October 5, 2010
Last Update Posted: October 12, 2017
Last Verified: August 2012

Keywords provided by Eli Lilly and Company:
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia,Blast Crisis

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes