A Study of LY2784544 in patients with blood cancer
- Conditions
- Myeloproliferative neoplasms (MPNs), myelofibrosis, essential thrombocythemia, and polycythemia veraMedDRA version: 20.1 Level: LLT Classification code 10036061 Term: Polycythemia vera System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10015493 Term: Essential thrombocythaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001012-56-AT
- 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
- Not specified
- Target Recruitment
- 188
[1]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:
A.PV:
i.have failed or is intolerant of standard therapies or refuses to take standard medications.
B.ET:
i.have failed or is intolerant of standard therapies or refuses to take standard medications.
C.MF (patients with MF must meet at least 1 of the following):
i.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
ii.have symptomatic MF with spleen greater than 10 cm below left costal margin; or
iii.have post-polycythemic MF; or
iv.have post-ET MF
All PV, ET, and MF patients must meet the following criteria:
[2]Have a quantifiable JAK2 V617F mutation. For patients in Dose Level 3, this inclusion criterion will not apply to the subset of patients in Cohorts 10 and 11 that are required to be negative for the JAK2 V617F mutation. This subset of patients must be negative for the mutation with unquantifiable levels of JAK2 V617F.
[3]Are ?18 years of age.
[4]Have given written informed consent prior to any study-specific procedures.
[5]Have adequate organ function, including:
Hepatic: 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/mcL, platelets =50,000 /mcL for patients with ET or PV and =25,000 /mcL for patients with MF.
[6]Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale (refer to Attachment 4).
[7]Have discontinued all previous approved therapies for 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.
[8]Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
[9]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.
[10]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.
[11]Are able to swallow capsules.
[12]For patients who have undergone recent maj
[13]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.
[14]Have a corrected QT (QTc) interval >470 msec using Bazett's formula.
[15]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).
[16]Are currently being treated with agents that are metabolized by CYP3A4 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).
[17]Are currently being treated with warfarin or 1 of its derivatives which is known to alter levels of protein C or protein S. An exception to this criterion will be allowed for patients with a prior history of Budd-Chiari Syndrome who are being treated with warfarin or 1 of its derivatives.
[18]Have received a hematopoietic stem cell transplant.
[19]Have a second primary malignancy that in the judgment of the Investigator and Sponsor may affect the interpretation of results.
[20]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).
[21]Have a history of congestive heart failure with New York Heart Association 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method