Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

110

participants targeted

Target at P50-P75 for phase_2

Timeline

6mo left

Started May 2012

Longer than P75 for phase_2

Geographic Reach

8 countries

36 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14.5 years study duration

Study Progress97%

May 2012Dec 2026

First Submitted

Initial submission to the registry

May 1, 2012

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed

13 days until next milestone

Study Start

First participant enrolled

May 22, 2012

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2015

Completed

11.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

May 1, 2012

Last Update Submit

July 22, 2025

Conditions

Neoplasms, Hematologic

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (19)

Percentage of Participants with a Molecular Response (Molecular Response Rate)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Percentage of Participants with Hematological Improvement (Hematological Improvement Rate)
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Spleen Size
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Bone Marrow Fibrosis Grade
Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
Change in Number of Thrombotic or Hemorrhagic Events
3 Months prior to Study Drug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)
+14 more secondary outcomes

Study Arms (1)

120 mg LY2784544

EXPERIMENTAL

120 milligram (mg) administered orally once daily for 6 cycles (168 days)

Drug: 120 mg LY2784544

Interventions

120 mg LY2784544DRUG

Administered orally

120 mg LY2784544

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
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
+1 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (39)

Highlands Oncology Group - Duplicate 2

Rogers, Arkansas, 72758, United States

Location

Providence St. Joseph's Medical Center

Burbank, California, 91505, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Palm Beach Cancer Institue

West Palm Beach, Florida, 33401, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Indiana Blood & Marrow Transplantation (IBMT)

Indianapolis, Indiana, 46237, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Mid Ohio Oncology Hematology

Columbus, Ohio, 43219, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Joe Arrington Cancer Center

Lubbock, Texas, 79410, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Dean Medical Center

Madison, Wisconsin, 53717, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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.

Garran, Australian Capital Territory, 2605, Australia

Location

Wodonga, Victoria, 3690, Australia

Location

Perth, Western Australia, 6009, Australia

Location

Vienna, 1090, Austria

Location

Montreal, Quebec, H1T 2M4, Canada

Location

Paris, 75010, France

Location

Jena, 07747, Germany

Location

Mannheim, 68167, Germany

Location

Minden, 32429, Germany

Location

Bologna, 40138, Italy

Location

Florence, 50134, Italy

Location

Barcelona, 08036, Spain

Location

Madrid, 28046, Spain

Location

Stockholm, SE-118 83, Sweden

Location

Uddevalla, 45180, Sweden

Location

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

LY2784544

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

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 DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 1, 2012

First Posted

May 9, 2012

Study Start

May 22, 2012

Primary Completion

March 20, 2015

Study Completion (Estimated)

December 1, 2026

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations

IT(2)CA(1)ES(2)AU(1)DE(3)FR(1)SE(3)US(23)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (19)

Study Arms (1)

120 mg LY2784544

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (39)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations