EUCTR2011-001012-56-ES进行中（未招募）不适用
A Phase 2 Study of LY2784544 in Patients withMyeloproliferative Neoplasms
illy S.A0 个研究点目标入组 150 人开始时间: 2012年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •[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:
- •i. have failed or is intolerant of standard therapies or refuses to take
- •standard medications.
- •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
- •[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.
- 另有 10 项未显示
排除标准
- •[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.
研究者
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