EUCTR2014-001345-24-BE进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND PHASE 1B/2 STUDY OF PF-04449913 IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH PREVIOUSLY UNTREATED INTERMEDIATE-2 OR HIGH-RISK MYELODYSPLASTIC SYNDROME, ACUTE MYELOID LEUKEMIA WITH 20-30% BLASTS AND MULTI-LINEAGE DYSPLASIA, OR CHRONIC MYELOMONOCYTIC LEUKEMIA
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 个研究点目标入组 170 人开始时间: 2015年1月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
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
- •Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1. Morphologically confirmed diagnosis of one of the following:
- •a. MDS according to WHO 2008 classification (See Appendix 1 of the protocol), and bone marrow blasts = 5%
- •b. AML with 20-30 % BM or PB blasts and multi-lineage dysplasia, according to WHO 2008 classification(Appendix 1 of the protocol) and WBC < 20x109/L
- •c. CMML according to the WHO 2008 classification (Appendix 1 of the protocol) and BM blasts between 10% - 19% and WBC < 13x109/L
- •2. MDS patients must have intermediate-2 (1.5 to 2.0 points) or High-Risk (=2.5 points) disease according to the International Prognostic Scoring System (IPSS).
- •3. MDS patients must have normal levels of vitimin B12 within the institutional range of normal as determined within 28 days of study entry.
- •4. AML pateients with 20-30% BM blasts and multi-linage dysplasia, must have stable blast counts per Investigator's judgment.
- •5. Clinical indication for treatment with azacitidine for MDS, AML or CMML.
- •6. Eastern Cooperatve Oncology Group (ECOG) Performance Status =2. See Appendix 11 of the protocol.
- •7. =18 years of age.
- •8. Adequate Renal Function:
- •a. Serum creatinine =1.5 x upper limit of normal (ULN);
- •b. Estimated creatinine clearance =60 ml/min (calculated using the standard method for the institution).
- •9. Adequate Liver Function:
- •a. Total serum bilirubin =1.5 x ULN (unless the bilirubin is principally unconjugated and there is strong suspicion of sub-clinical hemolysis or the patient has documented Gilbert's disease);
- •b. Aspartate transaminase (AST) and Alanine transaminase ( ALT) =2.5 x ULN;
- •c. Alkaline phosphatase =2.5 x ULN.
- •10. Serum amylase or lipase <1.5 x ULN.
- •11. Serum or urine pregnancy test (for female patients of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorinic gonadotropom (HCG) negative at screening.
- •12. Male and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective method(s) of contraception throughout the study and for 90 days after the last dose of azacitidine and the last dose of PF-04449913 or placebo, whichever occurs later.
- •13. Female patients who are not of childbearing potential (ie, meet at least 1 of the following criteria):
- •a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •b. Have medically confirmed overian failure; or
- •c. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.
- •14. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •15. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures (including BM assessments).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •Patients with any of the following may not be included in the study:
- •1. Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
- •2. Therapy-related (secondary to radiation or chemotherapy) MDS or
- •3. Prior hypomethylating agents or cytotoxic chemotherapy for MDS,
- •AML or CMML (prior immunosuppressive therapy and hydroxyurea are permitted provided that treatment is stopped within 8 and 2 weeks from study entry, respectively).
- •4. Previous hematopoietic stem cell transplant.
- •5. Prior treatment with a licensed or experimental smoothened inhibitor
- •(SMOi) and/or hypomethylating agent (HMA).
- •6. Participation in a clinical study involving an investigational drug(s) (Phases 1-4) within 4 weeks prior to study entry.
- •7. Major surgery or radiation within 12 weeks prior to study entry.
- •8. Patients known to be refractory to platelet or packed red cell transfusions as per institutional guidelines, or who are known to refuse or who are likely to refuse blood product support.
- •9. Treatment with hematopoietic growth factors including:
- •erythropoietin, granulocyte colony stimulating factor (G-CSF), and granulocyte macrophage colony stimulating factor (GM-CSF), or
- •thrombopoietin receptor agonists within 3 weeks prior to study entry.
- •10. Any ongoing medical condition requiring chronic use of moderate to igh dose steroids (defined as =10 mg/day of prednisone or equipotent dose of another corticosteroid).
- •11. Any anti-cancer treatment within 2 weeks prior to study entry.
- •12. Current use or anticipated requirement for drugs that are known
- •strong CYP3A4/5 inducers.
- •13. Diagnosis of any malignant disease other than MDS, AML or CMML
- •within the prior 12 months, with the exception of adequately treated: (i)
- •in-situ carcinomas, (ii) basal or squamous cell carcinoma, or (iii) nonmelanoma
- •skin cancer.
- •14. Known malabsorption syndrome or other condition that may impair the absorption of the study drug (eg, gastrectomy, lap band, Crohn's
- •disease) and inability or unwillingness to swallow tables or capsules.
- •15. Patients with active, uncontrolled bacterial, fungal or viral infection,
- •including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
- •16. Known uncontrolled central nervous system (CNS) involvement.
- •17. Known moderate to severe chronic obstructive pulmonary disease,
- •interstitial lung disease, or pulmonary fibrosis.
- •18. Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, hepatic tumors, non-alcoholic steatohepatitis [NASH]).
- •19. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient
- •ischemic attack or symptomatic pulmonary embolism; as well as
- •bradycardia defined as <50 bpms .
- •20. Active cardiac dysrhythmias of NCI CTCAE Grade =2 (eg, atrial fibrillation) or
- •QTcF interval >470 msec.
- •21. Pregnant or breastfeeding female patients.
- •22. Patients who are investigational site staff members directly involved in t
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