A Study for Patients With Acute Leukemia

Lilly

Status and phase: Terminated; Phase 1

Conditions: Acute Leukemia

Treatments: Drug: LY2523355

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214655

12119

I1Y-MC-JFBC (Other Identifier)

Details and patient eligibility

About

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 participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Dose escalation period for both schedules:

• Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and 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 acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have 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 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

LY2523355 on Days 1, 2, and 3

Experimental group

Description:

Starting dose was 2 milligrams per meter squared (mg/m\^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.

Treatment:

Drug: LY2523355

LY2523355 on Days 1, 5, and 9

Experimental group

Description:

Starting dose was 8 milligrams per meter squared (mg/m\^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.

Treatment:

Drug: LY2523355