NCT01520220

Brief Summary

The purpose of this study is to determine a dose of LY2784544 that may be safely administered to participants with myeloproliferative neoplasms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 10, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

June 11, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

January 10, 2012

Last Update Submit

April 10, 2017

Conditions

Myeloproliferative Neoplasms ofPolycythemia VeraEssential ThrombocythemiaMyelofibrosis

Outcome Measures

Primary Outcomes (2)

  • Number of participants with LY2784544 dose limiting toxicities (DLT)

    Baseline through Cycle 1 in Part A (28 day cycles)

  • Recommended dose range and regimen for Phase 2 studies

    Baseline through Cycle 1 in Part B (28 day cycles)

Secondary Outcomes (6)

  • Pharmacokinetics of LY2784544: Maximum concentration (Cmax)

    Cycle 1 in Part A and Part B (28 day cycles)

  • Pharmacokinetics of LY2784544: Area under the concentration-time curve (AUC)

    Cycle 1 in Part A and Part B (28 day cycles)

  • International Working Group (IWG) response

    Baseline through last Cycle in Part A and Part B (28 day cycles)

  • Dynamic International Prognostic Scoring System (DIPSS) Plus

    Baseline through last Cycle in Part A and Part B (28 day cycles)

  • Change in symptom burden as assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)

    Baseline, Last Cycle in Part A and Part B

  • +1 more secondary outcomes

Study Arms (4)

Part A: LY2784544 Dosing Regimen A

EXPERIMENTAL

LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days.

Drug: LY2784544

Part A: LY2784544 Dosing Regimen B

EXPERIMENTAL

LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses until reaching the highest dose a participant can tolerate. Each cycle is 28 days.

Drug: LY2784544

Part B: LY2784544 Dosing Regimen A

EXPERIMENTAL

LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days.

Drug: LY2784544

Part B: LY2784544 Dosing Regimen B

EXPERIMENTAL

LY2784544 will be taken by mouth per a specified schedule. Different participants will be treated at different doses from Part A that are determined to be safe and have potential clinical merit. Each cycle is 28 days.

Drug: LY2784544

Interventions

LY2784544DRUG

LY2784544 will be taken by mouth per a specified schedule. Each cycle is 28 days.

Part A: LY2784544 Dosing Regimen APart A: LY2784544 Dosing Regimen BPart B: LY2784544 Dosing Regimen APart B: LY2784544 Dosing Regimen B

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, primary or secondary) PV and ET participants must have failed or are intolerant of standard therapies or refuse to take standard medications
  • MF participants must meet at least one of the following criteria:
  • Have intermediate-1, intermediate-2, or high-risk MF according to the Dynamic International Prognostic Scoring System (DIPSS) plus; or
  • Have symptomatic MF with spleen greater than 10 cm below left costal margin; or
  • Have post-polycythemic MF (post-PV MF); or
  • Have post-essential thrombocythemic MF (post-ET MF)
  • All participants must meet the following criteria:
  • Have given written informed consent prior to any study-specific procedures
  • Have adequate organ function, including:
  • Hepatic: Direct bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine transaminase (ALT), and aspartate transaminase (AST) less than or equal to 2.5 times ULN
  • Renal: Serum creatinine less than or equal to 1.5 times ULN
  • Bone Marrow Reserve: Absolute neutrophil count (ANC) ≥1000/mcL, platelets ≥25,000/mcL, platelets ≥50,000 for PV or ET participants.
  • Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have discontinued all previous approved therapies for MF, 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 (GSF) 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 participant has been maintained on a stable dose for at least 4 weeks. Low dose acetylsalicylic acid (aspirin; 81 or 100 mg) 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
  • +4 more criteria

You may not qualify if:

  • Potential participants may not be included in the study if any of the following apply during screening:
  • Have received treatment within 14 days of the initial dose of study drug with an experimental agent that has not received regulatory approval for any indication
  • Have a QTc interval \>470 milliseconds (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 (GI) 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 (CYP)3A4 with a narrow therapeutic margin (for example, alfentanil, cyclosporine,diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) or CYP2B6 (for example, cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, and bupropion)
  • 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 the 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 greater than 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

Study Sites (9)

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.

Birmingham, Alabama, 35249, 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.

Scottsdale, Arizona, 85259, 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.

Fayetteville, Arkansas, 72703, 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.

Washington D.C., District of Columbia, 20007, 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.

Jacksonville, Florida, 32224, 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.

Honolulu, Hawaii, 96813, 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.

Charleston, South Carolina, 29425, 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.

Salt Lake City, Utah, 84132, 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.

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Polycythemia VeraThrombocythemia, EssentialPrimary Myelofibrosis

Interventions

LY2784544

Condition Hierarchy (Ancestors)

Bone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic Disorders

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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 27, 2012

Study Start

June 11, 2012

Primary Completion

June 26, 2015

Study Completion

February 24, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

US(9)