A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy and Safety of CC-486 (oral azacitidine) Alone and in Combination with Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine.

Celgene Corporation0 个研究点目标入组 194 人开始时间: 2016年3月18日最近更新: 2016年6月13日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 194

研究概览入排标准研究者记录与标识符相似试验

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. Male or female, >= 18 years of age at the time of signing the informed consent document.
•2. Documented diagnosis of myelodysplastic syndromes (MDS), classified according to French-American British (FAB) cooperation group classification criteria.
•3. Adequate course of treatment with an injectable hypomethylating agent (azacitidine for injection or decitabine) as the last therapeutic intervention for myelodysplastic syndromes prior to beginning screening for this study.
•4. Documented disease progression or stable disease as best response to treatment (or attempted treatment) with azacitidine for injection or decitabine. Those achieving an objective response to the most recent treatment regimen with an injectable HMA are excluded from participation in this study.
•5. Have the last dose of the prior treatment regimen (injectable hypomethylating agent (HMA) - azacitidine for injection or decitabine) not more than 12 weeks prior to screening for this study.
•6. No less than 3 weeks between the last dose of the prior treatment regimen (injectable HMA - azacitidine for injection or decitabine) and the planned date of first dose of investigative product.
•7. Have an Eastern Oncology Cooperative Group (ECOG) performance status of 0, 1, or 2.
•8. Females of childbearing potential may participate, providing they meet the following conditions:
•- Agree to use at least two effective contraceptive methods(oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; true abstinence; or vasectomized partner) throughout the study, and for 90 days following the last dose of IP; and
•- Have a negative serum pregnancy test at screening; and
•- Have a negative serum or urine pregnancy test within 72 hours prior to starting treatment with investigative product and before beginning each subsequent cycle of treatment.
•9. Male subjects with a female partner of childbearing potential must agree to use at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study and for 90 days following the last dose of investigational product.
•10. Understand and voluntarily sign an informed consent document prior to any study- related assessments or procedures conducted.
•11. Understand and voluntarily sign a biomarker-specific component of the informed consent document prior to any study-related procedures conducted.
•12. Be able to adhere to the study visit schedule and other protocol requirements.
•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 146

排除标准

•1. Rapidly-progressing MDS
•2. AML-FAB classification: >=30% blasts in bone marrow). Subjects known to have >= 30% blasts are not eligible for inclusion in this study. Recognizing limitations of blast cell quantification, this protocol will allow subjects with pre-enrollment (screening/baseline) bone marrow blast counts up to 33% to be considered for inclusion.
•3. Prior allogeneic or autologous stem cell transplant.
•4. Prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative
•5. Prior or ongoing response (IWG 2006: HI, PR),CR, or marrow CR) to treatment with azacitidine for injection or decitabine, including relapsed disease.
•6. Ongoing medically significant adverse events from previous treatment, regardless of the time period.
•7. Use of any of the following within 28 days prior to the first dose of IP:
•- thrombopoiesis-stimulating agents ([TSAs]; eg, Romiplostim, Eltrombopag, Interleukin-11)
•- ESAs and other RBC hematopoietic growth factors (eg, Interleukin-3)
•- hydroxyurea
•8. Concurrent use of corticosteroids unless the subject is on a stable or decreasing dose for >= 1 week prior to enrollment for medical conditions other than MDS
•9. History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the IP and/or predispose the subject to an increased risk of gastrointestinal toxicity.
•10. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for >=3 years. However, subjects with the following history/concurrent conditions are allowed:
•- Basal or squamous cell carcinoma of the skin
•- Carcinoma in situ of the cervix
•- Carcinoma in situ of the breast
•- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system)
•11. Significant active cardiac disease within the previous 6 months
•12. Uncontrolled systemic fungal, bacterial, or viral infection (ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
•13. Known HIV or HCV infection, or evidence of active HBV infection
•14. Any of the following laboratory abnormalities:
•- Serum AST/SGOT) or ALT/SGPT > 2.5 x ULN
•- Serum total bilirubin > 1.5 x ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > 2% with either a positive Coombs' test or over 50% of indirect bilirubin
•- Serum creatinine > 2.5 x ULN
•- Absolute WBC) count >= 20 x 10*9/L
•15. Known or suspected hypersensitivity to azacitidine or mannitol, or durvalumab its constituents, or to any other humanized monoclonal antibody
•16. Pregnant or breast-feeding females
•17. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
•18. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
•19. Any condition that confounds the ability to interpret data from the study, including kn

研究者

发起方

Celgene Corporation

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