Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Cohort 1: 40 milligrams (mg) LY2090314 administered on Days 1, 8, and 15 of a 28-day cycle for at least two (2) 28-day cycles. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met.

Due to a protocol amendment on September 2010, the study added 2 additional treatment schedules/cohorts. Cohort 2: 40 mg dose given on Days 1, 5, and 9 of a 21-day cycle. Cohort 3: 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.

LY2090314

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)

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

A Study in Participants With Acute Leukemia

A Phase 2 Study of LY2090314 in Participants With Acute Leukemia

Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

The Revised International Working Group criteria were used to determine the response for participants with acute myelogenous leukemia (AML). Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/Liter (L) and absolute neutrophil count (ANC) ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.

The Revised International Working Group criteria were used to determine the response for participants with AML. Complete response, also known as complete remission (CR) included the following categories: Morphologic CR defined as \<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells, along with peripheral blood levels including platelets ≥100\*10\^9/L and ANC ≥1\*10\^9/L, Morphologic CR with incomplete blood count recovery (CRi), Cytogenetic CR, and Molecular CR. Partial response, also known as partial remission (PR) was defined as a decrease of at least 50% in blast count on the bone marrow aspirate. PR required all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Percentage of participants=\[(number of participants with CR or PR)/(number of participants treated)\]\*100.

AUC(0-8) was estimated from the plasma drug concentration time profile.

AUC(0-inf) was estimated from the plasma drug concentration time profile.

Cmax is the maximum observed concentration estimated from the plasma drug concentration time profile.

Percent change=\[(β-catenin level postdose-predose level)/(predose β-catenin levels)\]\*100. Participants in Cohort 1 had β-catenin samples collected on Cycle 1: D1, D8, and D15, and Cycles 2 through 9: D1. Participants in Cohort 2 had β-catenin samples collected on Cycle 1: D1, D5, and D9 and Cycles 2 through 9: D1. Participants in Cohort 3 had β-catenin samples collected on Cycle 1: D1, D5, D9, and D12 and Cycles 2 through 9: D1.

The number of participants who died while on study treatment and the number of participants who died during the 30-day follow-up (30 days post last dose) are reported.

Eli Lilly and Company

LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.

If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.

Cohort 1, 40 mg LY2090314: D1, D8, D15

LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.

If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.

Cohort 2, 40 mg LY2090314: D1, D5, D9

LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.

If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.

Cohort 3, 40 mg LY2090314: D1, D5, D9, D12

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All participants who received at least 1 dose of LY2090314.

An interim data review was performed after 6 participants in the safety lead-in completed 1 cycle of therapy. Based on the interim safety results, the expansion cohort was not opened to enrollment.

Chief Medical Officer

Study Drug-Related AE(s)

Study Drug-Related SAE(s)

Participants who received at least 1 dose of study drug.

Number of Participants With 1 or More Study Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)

Number of Participants With Best Response of Complete Response or Partial Response

Percentage of Participants With Best Response of Complete Response or Partial Response

All participants who received at least 1 dose of LY2090314 regardless of the cohort to which they were enrolled.

Cohort 1: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D8, and D15 for two 28-day cycles.

Cohort 2: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, and D9 for two 21-day cycles.

Cohort 3: LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on D1, D5, D9, and D12 for two 21-day cycles.

If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.

Entire Study Population

Participants who received at least 1 dose of study drug and had sufficient postdose samples collected to allow estimation of the PK parameters using noncompartmental methods of analysis.

Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to 8 Hours (h) Postdose [AUC(0-8)]

PK: AUC From Time 0 to Infinity [AUC(0-inf)]

PK: Maximum Concentration (Cmax)

Cycle 1, Day 1, 1 h postdose

Cycle 1, Day 1, 2 h postdose

Cycle 1, Day 1, 4 h postdose

Cycle 1, Day 1, 8 h postdose

Cycle 1, Day 1, 24 h postdose

Cycle 1, Day 5, 2 h postdose

Cycle 1, Day 8, 2 h postdose

Cycle 1, Day 9, 1 h postdose

Cycle 1, Day 9, 2 h postdose

Cycle 1, Day 9, 4 h postdose

Cycle 1, Day 9, 8 h postdose

Cycle 1, Day 9, 24 h postdose

Cycle 1, Day 12, 2 h postdose

Cycle 1, Day 15, 1 h postdose

Cycle 1, Day 15, 2 h postdose

Cycle 1, Day 15, 4 h postdose

Cycle 1, Day 15, 8 h postdose

Cycle 2, Day 1, 2 h postdose

Cycle 3, Day 1, 2 h postdose

Cycle 4, Day 1, 2 h postdose

Cycle 5, Day 1, 2 h postdose

Cycle 6, Day 1, 2 h postdose

Cycle 7, Day 1, 2 h postdose

Cycle 8, Day 1, 2 h postdose

Cycle 9, Day 1, 2 h postdose

Participants who received at least 1 dose of study drug and had a predose and at least 1 postdose β-catenin sample collected.

Percent Change From Predose Beta (β)-Catenin Levels

Death On Study, Prior To Cycle 2 Completion

Death On Study, Post Cycle 2 Completion

Death During 30-Day Follow-Up

Number of Participants Who Died

LY2090314: 40 mg administered as an intravenous infusion over 60-minutes on Day (D)1, D8, and D15 for two 28-day cycles.

If therapeutically beneficial, participants could continue additional treatment cycles until death, disease progression or other study discontinuation criteria were met.

Spots Global Cancer Trial Database for A Study in Participants With Acute Leukemia

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial