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A Phase 2 Study of LY2090314 in Participants With Acute Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Phase 2 Study of LY2090314 in Participants With Acute Leukemia


Inclusion Criteria:



- Participants must have confirmed diagnosis of one of the following:

- Acute myelogenous leukemia (AML) that is refractory or relapsed disease. If
participants have acute promyelocytic leukemia (APL), they must have received
prior all-trans retinoic acid and arsenic trioxide unless ineligible or
intolerant to them

- Untreated AML (de novo or arising from a myelodysplastic syndrome). In the
opinion of the investigator, the participant should not be a candidate for
standard therapy and a clinical trial is a preferred treatment option

- Have given written informed consent prior to any study-specific procedures

- Have adequate organ function including:

- Hepatic: Bilirubin less than or equal to 1.5 times the upper limit of normal
(ULN). Alkaline phosphatase and transaminases (ALT and AST) less than or equal
to 5 times ULN

- Renal: Serum creatinine less than or equal to the ULN. No known active renal
disease. In rare cases, participants may enter treatment with a serum creatinine
greater than the ULN as elevations of serum creatinine may be secondary to
dehydration

- Have a performance status of less than than or equal to 2 on the Eastern Cooperative
Oncology Group (ECOG) scale

- Have discontinued all previous approved therapies for acute leukemia, including
chemotherapy for at least 14 days, and recovered from the acute effects of therapy.
Hydroxyurea used to control peripheral blast count is permitted within the first 2
cycles of treatment on study, but it must be stopped at least 24 hours before study
drug administration in Cycle 3

- Are reliable and willing to be available for the duration of the study and are
willing to follow study procedures

- Males and females with reproductive potential must agree to use medically approved
contraceptive precautions during the trial and for 3 months following the last dose
of study drug

- 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

- Have an estimated life expectancy of greater than or equal to 6 weeks

Exclusion Criteria:

- Have received treatment within 14 days of the initial dose of study drug with an
experimental agent for noncancer indications that has not received regulatory
approval for any indication

- Participants with Chronic Myelogenous Leukemia (CML) including blast crisis phase

- Participants with known central nervous system (CNS) leukemia by spinal fluid
cytology or imaging

- Have serious pre-existing medical conditions (left to the discretion of the
investigator)

- Have one of the following abnormalities: QTc (Fridericia corrected) interval >450
milliseconds (msec) on screening electrocardiogram (ECG), previous history of QTc
prolongation with another medication that required discontinuation, congenital long
QT syndrome, previous history of ventricular tachycardia or unexplained syncope, left
bundle branch block, or chronic atrial fibrillation

- Have family history of long QT syndrome or sudden death due to ventricular arrhythmia

- Concomitant medication that may cause QTc prolongation or induce Torsades de Pointes
at the time of study entry

- Have systolic blood pressure greater than or equal to 160 millimeter of mercury (mm
Hg) and diastolic blood pressure greater than or equal to 100 mm Hg

- Have a serious cardiac condition, such as myocardial infarction within 6 months,
angina, or heart disease, as defined by the New York Heart Association Class II or
higher or participants with a history of arrhythmia that is symptomatic or requires
treatment

- Have uncorrected electrolyte disorders including potassium

- Have other active malignancy (with the exception of basal and squamous cell skin
cancer) at time of study entry

- Have received an autologous or allogeneic stem-cell transplant within 75 days of the
initial dose of study drug

- Have uncontrolled systemic infection

- Females who are pregnant or lactating

- Presence of clinical evidence of viral disease caused by human immunodeficiency
virus, hepatitis B, or hepatitis C

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with one or more drug related Adverse Events (AEs) or any Serious AE's

Outcome Time Frame:

Baseline to study completion (estimated up to 1.5 months)

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 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:

13370

NCT ID:

NCT01214603

Start Date:

November 2010

Completion Date:

December 2012

Related Keywords:

  • Leukemia
  • Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute
  • Leukemia, Leukemia
  • Leukemia

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.Durham, North Carolina  
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.Minneapolis, Minnesota  55404
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