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:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01214655
First received: October 1, 2010
Last updated: August 1, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for both schedules ] [ Designated as safety issue: No ]
  • Response Rate for acute myelogenous leukemia using The Revised International Working Group Criteria [ Time Frame: Baseline to disease progression or discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Cycle 1 and Cycle 2 at each dose level for both schedules ] [ Designated as safety issue: No ]
  • Response rate for acute lymphoblastic leukemia using The Revised International Working Group Criteria [ Time Frame: Baseline to disease progression or discontinuation ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214655     History of Changes
Other Study ID Numbers: 12119, I1Y-MC-JFBC
Study First Received: October 1, 2010
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014