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LY2510924, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02652871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-11-15

No results posted yet for this study

Summary

The goal of this clinical research study is to learn about the safety of LY2510924 in combination with cytarabine and idarubicin in patients with relapsed or refractory AML. We will also study if LY2510924 in combination with cytarabine and idarubicin can help to control relapsed or refractory AML.

LY2510924 is designed to help cancer cells move from the bone marrow into the bloodstream, where they are exposed to chemotherapy (in this case, cytarabine and idarubicin).

This is an investigational study. LY2510924 is not FDA approved or commercially available. Its use in this study is investigational. Cytarabine and idarubicin are approved to treat certain types of leukemia. Their use in this study in combination with LY2510924 is investigational.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Conditions

Interventions

DRUG

LY2510924

Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients. Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase.

DRUG

Idarubicin

Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients \> 60 years of age Idarubicin given for 2 days. Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days.

DRUG

Cytarabine

Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age \< 60 years). In patients \> 60 years of age Cytarabine given for 3 days only. Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • High Impact Clinical Research Support Program

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Marina Konopleva, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-09
Primary Completion
2019-07-16
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652871 on ClinicalTrials.gov