A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

July 22, 2025 updated by: Eli Lilly and Company

A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • 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.
    • Victoria
      • Wodonga, Victoria, Australia, 3690
        • 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.
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • 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.
  • Austria
      • Wien, Austria, 1090
        • 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.
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • 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.
  • France
      • Paris, France, 75010
        • 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.
  • Germany
      • Jena, Germany, 07747
        • 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.
      • Mannheim, Germany, 68167
        • 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.
      • Minden, Germany, 32429
        • 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.
  • Italy
      • Bologna, Italy, 40138
        • 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.
      • Firenze, Italy, 50134
        • 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.
  • Spain
      • Barcelona, Spain, 08036
        • 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.
      • Madrid, Spain, 28046
        • 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.
  • Sweden
      • Stockholm, Sweden, SE-118 83
        • 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.
      • Uddevalla, Sweden, 45180
        • 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.
      • Uppsala, Sweden, 75185
        • 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.
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group - Duplicate 2
    • California
      • Burbank, California, United States, 91505
        • Providence St. Joseph's Medical Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institue
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indiana Blood & Marrow Transplantation (IBMT)
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology Hematology
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
    • Texas
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Dean Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Swerdlow et al. 2008) and meet the following additional subtype specific criteria:

    • PV: have failed or is intolerant of standard therapies or refuses to take standard medications
    • ET: have failed or is intolerant of standard therapies or refuses to take standard medications
    • MF (participants with MF must meet at least 1 of the following): have intermediate 1, intermediate 2, or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPPS Plus) for Primary Myelofibrosis (Gangat et al. 2011); or have symptomatic MF with spleen greater than 10 centimeter (cm) below left costal margin; or have post-polycythemic MF; or have post-ET MF

  • All PV, ET, and MF participants must meet the following criteria:

    o Have a quantifiable level of janus kinase 2 with a valine to phenylalanine substitution at amino acid 617 (JAK2 V617F) mutation. This inclusion criterion will not apply to the subset of participants in Cohorts 10 and 11 that must be negative for the JAK2 V617F mutation

  • Are ≥ 18 years of age
  • Have given written informed consent prior to any study-specific procedures
  • Have adequate organ function, including: Hepatic: Direct bilirubin ≤1.5 times upper limits of normal (ULN), alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5 times ULN; Renal: Serum creatinine ≤1.5 times ULN; Bone Marrow Reserve: Absolute neutrophil count (ANC) ≥1000/microliter (mcL), platelets ≥50,000/mcL for participants with ET or PV and ≥25,000/mcL for participants with MF
  • Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued all previous approved therapies for Myeloproliferative Neoplasms (MPNs), including any chemotherapy, immunomodulating therapy (for example, thalidomide, interferon-alpha), immunosuppressive therapy (for example, corticosteroids >10 mg/day prednisone or equivalent), radiotherapy, and erythropoietin, thrombopoietin, or granulocyte colony stimulating factor for at least 14 days and recovered from the acute effects of therapy. Hydroxyurea used to control blood cell counts is permitted at study entry if the subject has been maintained on a stable dose for at least 4 weeks. Low-dose acetylsalicylic acid (aspirin) is permitted as well
  • Are reliable and willing to make themselves 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 study and for 3 months following the last dose of study drug
  • Females with child-bearing potential must have had a negative urine pregnancy test ≤ 7 days before the first dose of study drug and must also not be breastfeeding
  • Are able to swallow capsules
  • For participants who have undergone recent major surgery, at least 28 days must have elapsed between surgery and study participation and the participant must have achieved, in the opinion of the treating physician, at least a good recovery from the surgical procedure
  • Enrollment into Cohort 12 is limited to MF, PV, or ET participants, regardless of mutational status, who, in addition to all other criteria, have demonstrated intolerance to ruxolitinib, failure of primary response to ruxolitinib, or have demonstrated disease progression while on ruxolitinib

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 14 days from a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have a corrected QT (QTc) interval >470 millisecond (msec) using Bazett's formula
  • Have serious preexisting medical conditions that, in the opinion of the investigator would preclude participation in the study (for example a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome)
  • Are currently being treated with agents that are metabolized by Cytochrome P450 3A4 enzyme (CYP3A4) with a narrow therapeutic margin (for example, alfentanil, cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or Cytochrome P450 2B6 enzyme (CYP2B6) (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
  • Are currently being treated with warfarin or one of its derivatives which is known to alter levels of protein C or protein S. An exception to this criterion will be allowed for participants with a prior history of Budd-Chiari Syndrome who are being treated with warfarin or one of its derivatives
  • Have received a hematopoietic stem cell transplant
  • Have a second primary malignancy that in the judgment of the Investigator and Sponsor may affect the interpretation of results
  • Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)
  • Have a history of congestive heart failure with New York Heart Association (NYHA) Class >2 (NYHA Class 1 and 2 are eligible), unstable angina, recent myocardial infarction (within 6 months prior to administration of study drug), or documented history of ventricular arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 120 mg LY2784544
120 milligram (mg) administered orally once daily for 6 cycles (168 days)
Drug: 120 mg LY2784544
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with an Objective Response (Objective Response Rate)
Time Frame: Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 24 Months)
Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 24 Months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with a Molecular Response (Molecular Response Rate)
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Percentage of Participants with Hematological Improvement (Hematological Improvement Rate)
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Spleen Size
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Bone Marrow Fibrosis Grade
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Number of Thrombotic or Hemorrhagic Events
Time Frame: 3 Months prior to Study Drug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)
3 Months prior to Study Drug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Number of Phlebotomies and Transfusions
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Duration of Response
Time Frame: Confirmed Response to PD or Death from Any Cause (Estimated up to 24 Months)
Confirmed Response to PD or Death from Any Cause (Estimated up to 24 Months)
Time to Best Response
Time Frame: Baseline to Confirmed Response (Estimated up to 6 Months)
Baseline to Confirmed Response (Estimated up to 6 Months)
Change in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Time to Treatment Failure
Time Frame: Baseline to PD, Death from Any Cause or Participant Stops Study (Estimated up to 24 Months)
Baseline to PD, Death from Any Cause or Participant Stops Study (Estimated up to 24 Months)
Time to Disease Progression
Time Frame: Baseline to Measured PD (Estimated up to 24 Months)
Baseline to Measured PD (Estimated up to 24 Months)
Progression Free Survival (PFS)
Time Frame: Baseline to PD or Death from Any Cause (Estimated up to 24 Months)
Baseline to PD or Death from Any Cause (Estimated up to 24 Months)
Change in Activities of Daily Living (ADL)/ Instrumental Activities of Daily Living (IADL)
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in EuroQol - 5 dimensions (EQ-5D) Index Score
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in International Prognosis Scoring System Scales (IPSS)
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2784544
Time Frame: Predose up to Day 84
Predose up to Day 84
PK: Time of Maximal Concentration (Tmax) of LY2784544
Time Frame: Predose up to Day 84
Predose up to Day 84
Change in Liver Size
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in 6-item Physician Symptom Assessment
Time Frame: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2012

Primary Completion (Actual)

March 20, 2015

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 1, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimated)

May 9, 2012

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13861
  • I3X-MC-JHTB (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms, Hematologic

Clinical Trials on 120 mg LY2784544

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe