A Study of LY2784544 in Patients with blood cancer

Conditions: Myeloproliferative neoplasms (MPNs), myelofibrosis, essentialthrombocythemia, and polycythemia vera
MedDRA version: 15.0Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 15.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 15.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2011-001012-56-IT

Lead Sponsor: ELI LILLY AND COMPANY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 188

Inclusion Criteria

Patients must have a diagnosis of PV, ET, or MF as defined by the World Health Organization diagnostic criteria for MPNs. Patients must have discontinued all previous approved therapies for MPNs. Patients must be greater than 18 years of age and both males and females can be enrolled. Patients must have adequate bone marrow reserve: absolute neutrophil count =1000/mcL, platelets =50,000/mcL for patients with ET or PV, and =25,000/mcL for patients with MF.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients will be excluded if they have a corrected QT (QTc) interval >470 msec, are currently being treated with agents that are metabolized by CYP3A4 or CYP2B6 with a narrow therapeutic margin, are currently being treated with warfarin, have received a hematopoietic stem cell transplant, or have a history of congestive heart failure with New York Heart Association Class >2, unstable angina, recent myocardial infarction or documented history of ventricular arrhythmia.