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A Study of LY2784544 in Participants With Myeloproliferative Neoplasms | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms

NCT01594723•Eli Lilly and Company

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

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

Locations (39)

Highlands Oncology Group - Duplicate 2

Rogers, Arkansas, United States

Providence St. Joseph's Medical Center

Burbank, California, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Palm Beach Cancer Institue

West Palm Beach, Florida, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Indiana Blood & Marrow Transplantation (IBMT)

Indianapolis, Indiana, United States

Cancer Center of Kansas

Wichita, Kansas, United States

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

May 22, 2012

Primary Completion Date

March 20, 2015

Completion Date

December 1, 2026

Last Updated

July 23, 2025

Enrollment

110

ESTIMATED participants

Conditions

Neoplasms, Hematologic

Interventions

120 mg LY2784544

DRUG