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
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, see Learn About Clinical Studies.

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 July 22, 2014