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Neoplasms, HematologicPhase 2NCT01594723

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

A Phase 2 study testing 120 mg LY2784544 in people with Neoplasms, Hematologic, run by Eli Lilly and Company at 39 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Hematologic
What is being tested?
120 mg LY2784544
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
39 sitesin 9 countries
Study dates
22 May 2012to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

39 sites in 9 countries.

39 sites in 9 countries

United States23 sites

  • Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Providence St. Joseph's Medical Center

    Burbank, California, 91505

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mid Ohio Oncology Hematology

    Columbus, Ohio, 43219

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Indiana Blood & Marrow Transplantation (IBMT)

    Indianapolis, Indiana, 46237

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410

  • Dean Medical Center

    Madison, Wisconsin, 53717

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Weill Cornell Medical College

    New York, New York, 10021

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Highlands Oncology Group - Duplicate 2

    Rogers, Arkansas, 72758

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Washington University Medical Center

    St Louis, Missouri, 63110

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Palm Beach Cancer Institue

    West Palm Beach, Florida, 33401

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Australia3 sites

  • 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

  • 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.

    Perth, Western 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.

    Wodonga, Victoria, 3690

Other trials in Australia

Germany3 sites

  • 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.

    Jena, 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, 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, 32429

Other trials in Germany

Sweden3 sites

  • 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.

    Stockholm, 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, 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, 75185

Other trials in Sweden

Italy2 sites

  • 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.

    Bologna, 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.

    Florence, 50134

Other trials in Italy

Spain2 sites

  • 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.

    Barcelona, 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, 28046

Other trials in Spain

Austria1 site

  • 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.

    Vienna, 1090

Other trials in Austria

Canada1 site

  • 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.

    Montreal, Quebec, H1T 2M4

Other trials in Canada

France1 site

  • 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.

    Paris, 75010

Other trials in France

About this study

Official title: 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.

Being tested
120 mg LY2784544
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 120 mg LY2784544Drug

    Administered orally

Study groups in NCT01594723
Study groupRoleWhat they receive
120 mg LY2784544Experimental120 milligram (mg) administered orally once daily for 6 cycles (168 days)
Receives: Drug: 120 mg LY2784544

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with an Objective Response (Objective Response Rate)

    Measured: Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 24 Months)

Secondary outcomes (19)

  1. Percentage of Participants with a Molecular Response (Molecular Response Rate)

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  2. Percentage of Participants with Hematological Improvement (Hematological Improvement Rate)

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  3. Change in Spleen Size

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  4. Change in Bone Marrow Fibrosis Grade

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  5. Change in Number of Thrombotic or Hemorrhagic Events

    Measured: 3 Months prior to Study Drug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)

  6. Change in Number of Phlebotomies and Transfusions

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  7. Duration of Response

    Measured: Confirmed Response to PD or Death from Any Cause (Estimated up to 24 Months)

  8. Time to Best Response

    Measured: Baseline to Confirmed Response (Estimated up to 6 Months)

  9. Change in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  10. Time to Treatment Failure

    Measured: Baseline to PD, Death from Any Cause or Participant Stops Study (Estimated up to 24 Months)

  11. Time to Disease Progression

    Measured: Baseline to Measured PD (Estimated up to 24 Months)

  12. Progression Free Survival (PFS)

    Measured: Baseline to PD or Death from Any Cause (Estimated up to 24 Months)

  13. Change in Activities of Daily Living (ADL)/ Instrumental Activities of Daily Living (IADL)

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  14. Change in EuroQol - 5 dimensions (EQ-5D) Index Score

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  15. Change in International Prognosis Scoring System Scales (IPSS)

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  16. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2784544

    Measured: Predose up to Day 84

  17. PK: Time of Maximal Concentration (Tmax) of LY2784544

    Measured: Predose up to Day 84

  18. Change in Liver Size

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

  19. Change in 6-item Physician Symptom Assessment

    Measured: Baseline until PD or Participant Stops Study (Estimated up to 24 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2012 (estimated)
  2. Study start22 May 2012
  3. Primary completion20 Mar 2015
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01594723
Sponsor's protocol ID
13861
Other IDs
I3X-MC-JHTB
Status last verified
Jun 2026
First submitted
1 May 2012
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 120 mg LY2784544 in people with Neoplasms, Hematologic, run by Eli Lilly and Company at 39 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Australia, Germany, Sweden, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01594723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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