A Study in Participants With Acute Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01214603
First received: September 29, 2010
Last updated: April 30, 2013
Last verified: February 2013
  Purpose

Study JWYB is a multicenter, non-randomized, open-label, Phase 2 study of intravenous LY2090314 in participants with acute leukemia.


Condition Intervention Phase
Leukemia
Drug: LY2090314
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of LY2090314 in Participants With Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with one or more drug related Adverse Events (AEs) or any Serious AE's [ Time Frame: Baseline to study completion (estimated up to 1.5 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Best Response of Partial Response or Complete Response [ Time Frame: Baseline to progressive disease (estimated up to 1.5 months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) [ Time Frame: Predose up to 24 hours on Cycle 1 Day 1, Day 9 and Predose up to 2 hours on Cycle 1 Day 5 and Day 12 (if applicable) and subsequent Cycles Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Concentration (Cmax) [ Time Frame: Predose up to 24 hours on Cycle 1 Day 1, Day 9 and Predose up to 2 hours on Cycle 1 Day 5 and Day 12 (if applicable) and subsequent Cycles Day 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Best Response of Partial Response or Complete Response [ Time Frame: Baseline to progressive disease (estimated up to 1.5 months) ] [ Designated as safety issue: No ]
  • Change in β-catenin levels over time [ Time Frame: Multiple timepoints of collection from baseline to study conclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2090314

The dose to be evaluated is 40mg LY2090314 administered on days 1, 8 and 15 of a 28 day cycle for at least two (2) 28 day cycles. Patients experiencing clinical benefit may continue treatment until after the discontinuation criteria are met.

Due to amendment on September 2010, study added two additional treatment schedules. Schedule 1 is a 40 mg dose given on Days 1, 5, and 9 of a 21-day cycle. Schedule 2 is 40 mg dose given on Days 1, 5, 9, and 12 of a 21-day cycle. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met.

Drug: LY2090314
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01214603

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, 60637
United States, Minnesota
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, United States, 55455
United States, 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.
Durham, North Carolina, United States, 27710
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, 77030
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01214603     History of Changes
Other Study ID Numbers: 13370, I2H-MC-JWYB
Study First Received: September 29, 2010
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute
Leukemia, Leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014