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Phase 1 Study of LY2523355 in Patients With Acute Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Leukaemia

Thank you

Trial Information

Phase 1 Study of LY2523355 in Patients With Acute Leukemia


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended dose and schedule for Phase 2 studies in acute leukemia

Outcome Time Frame:

Baseline to study completion

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12119

NCT ID:

NCT01214655

Start Date:

June 2008

Completion Date:

February 2011

Related Keywords:

  • Acute Leukaemia
  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia,Blast Crisis
  • Leukemia
  • Acute Disease

Name

Location

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  60674
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  46227
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Springfield, Massachusetts