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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01594723
Registration number
NCT01594723
Ethics application status
Date submitted
1/05/2012
Date registered
9/05/2012
Date last updated
21/03/2024
Titles & IDs
Public title
A Study of LY2784544 in Participants With Myeloproliferative Neoplasms
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Scientific title
A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms
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Secondary ID [1]
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I3X-MC-JHTB
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Secondary ID [2]
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13861
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Hematologic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 120 mg LY2784544
Experimental: 120 mg LY2784544 - 120 milligram (mg) administered orally once daily for 6 cycles (168 days)
Treatment: Drugs: 120 mg LY2784544
Administered orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with an Objective Response (Objective Response Rate)
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Assessment method [1]
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Timepoint [1]
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Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [1]
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Percentage of Participants with a Molecular Response (Molecular Response Rate)
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Assessment method [1]
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Timepoint [1]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [2]
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Percentage of Participants with Hematological Improvement (Hematological Improvement Rate)
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Assessment method [2]
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Timepoint [2]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [3]
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Change in Spleen Size
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Assessment method [3]
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Timepoint [3]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [4]
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Change in Bone Marrow Fibrosis Grade
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Assessment method [4]
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Timepoint [4]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [5]
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Change in Number of Thrombotic or Hemorrhagic Events
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Assessment method [5]
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Timepoint [5]
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3 Months prior to Study Drug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [6]
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Change in Number of Phlebotomies and Transfusions
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Assessment method [6]
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Timepoint [6]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [7]
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Duration of Response
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Assessment method [7]
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Timepoint [7]
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Confirmed Response to PD or Death from Any Cause (Estimated up to 24 Months)
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Secondary outcome [8]
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Time to Best Response
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Assessment method [8]
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Timepoint [8]
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Baseline to Confirmed Response (Estimated up to 6 Months)
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Secondary outcome [9]
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Change in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
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Assessment method [9]
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Timepoint [9]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [10]
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Time to Treatment Failure
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Assessment method [10]
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Timepoint [10]
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Baseline to PD, Death from Any Cause or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [11]
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Time to Disease Progression
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Assessment method [11]
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Timepoint [11]
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Baseline to Measured PD (Estimated up to 24 Months)
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Secondary outcome [12]
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Progression Free Survival (PFS)
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Assessment method [12]
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Timepoint [12]
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Baseline to PD or Death from Any Cause (Estimated up to 24 Months)
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Secondary outcome [13]
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Change in Activities of Daily Living (ADL)/ Instrumental Activities of Daily Living (IADL)
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Assessment method [13]
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Timepoint [13]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [14]
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Change in EuroQol - 5 dimensions (EQ-5D) Index Score
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Assessment method [14]
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Timepoint [14]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [15]
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Change in International Prognosis Scoring System Scales (IPSS)
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Assessment method [15]
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Timepoint [15]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [16]
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2784544
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Assessment method [16]
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Timepoint [16]
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Predose up to Day 84
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Secondary outcome [17]
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PK: Time of Maximal Concentration (Tmax) of LY2784544
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Assessment method [17]
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Timepoint [17]
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Predose up to Day 84
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Secondary outcome [18]
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Change in Liver Size
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Assessment method [18]
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Timepoint [18]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Secondary outcome [19]
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Change in 6-item Physician Symptom Assessment
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Assessment method [19]
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Timepoint [19]
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Baseline until PD or Participant Stops Study (Estimated up to 24 Months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,VIC,WA
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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. - Nedlands
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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3690 - Wodonga
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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Florida
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United States of America
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Missouri
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Nebraska
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New York
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Ohio
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Tennessee
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Texas
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Washington
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Wisconsin
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Austria
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Wien
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Canada
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Quebec
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France
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Paris
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Germany
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Jena
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Germany
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Mannheim
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Germany
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Minden
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Italy
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Bologna
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Italy
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Firenze
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Stockholm
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Sweden
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Uddevalla
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Sweden
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01594723
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01594723
Download to PDF