Clinical trial NCT01214655: A Study for Patients With Acute Leukemia
Official title: Phase 1 Study of LY2523355 in Patients With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Leukemia
Keywords: Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia,Blast Crisis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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).

Primary outcomes:
measure: Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia
timeFrame: Baseline up to the end of Cycle 2 (Day 42)
Secondary outcomes:
measure: Number of Participants With Clinically Significant Effects
timeFrame: Baseline up to study completion (up to 213 days)
measure: Pharmacokinetics, Maximum Plasma Concentration (Cmax), Single Dose
timeFrame: Cycle 1(Day 1),: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose
measure: Pharmacokinetics, Maximum Plasma Concentration (Cmax), Multiple Dose
timeFrame: Days 3 (Parts A or C) or 9 (Part B), Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose
measure: Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC), Single Dose
timeFrame: Day 1, Cycle 1: Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr, 48 hr, 72 hr postdose
measure: Pharmacokinetics, Area Under the Concentration Versus Time (AUC), Multiple Dose
timeFrame: Days 3 (Parts A or C) or 9 (Part B):Predose, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8, hr, 12 hr, 24 hr 48 hr, 72 hr postdose
measure: Percentage of Participants With a Response for Acute Myelogenous Leukemia Using The Revised International Working Group Criteria
timeFrame: Baseline up to disease progression or discontinuation (up to 213 days)
measure: Response Rates for Chronic Myelogenous Leukemia in Blast Crisis (Complete Hematologic Response, no Evidence of Leukemia, Return to Chronic Phase)
timeFrame: Baseline up to disease progression or discontinuation (up to 213 days)
measure: Response Rate (Percentage) for Acute Lymphoblastic Leukemia Using The Revised International Working Group Criteria
timeFrame: Baseline up to disease progression or discontinuation (up to 213 days)
Other outcomes:
measure: Death of Participants on Study up to the Follow-up Period
timeFrame: Baseline up to end of treatment follow-up (up to 213 days)
Locations:
city: Chicago
country: United States
facility: 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.
state: Illinois
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: Boston
country: United States
facility: 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.
state: Massachusetts
city: Nashville
country: United States
facility: 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.
state: Tennessee
city: Houston
country: United States
facility: 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.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: