EUCTR2011-001847-58-FR进行中（未招募）1 期
A Randomized Phase II, Open-Label study of the Efficacy and Safety of Orally Administered SAR302503 in patients with polycythemia vera (PV) or essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
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
- •Diagnosis of hydroxyurea resistant or intolerant polycythemia vera (PV) or essential thrombocythemia (ET).
- •Polycythemia vera or essential thrombocythemia defined according to the revised WHO criteria
- •Polycythemia vera resistance or intolerance to hydroxyurea is defined as polycythemia vera patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months.
- •Essential thrombocythemia resistance or intolerance to hydroxyurea is defined as essential thrombocythemia patients on hydroxyurea with platelet count >600 x 10 exp9/L.
- •Provide written informed consent to participate.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Less than 18 years of age.
- •Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.)
- •Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
- •Eastern Cooperative Oncology Group performance status of 3 or 4 at study entry.
- •Splenectomy.
- •Contraindications for undergoing magnetic resonance imaging in patients with palpable spleens (eg, metal implants).
- •Any chemotherapy (eg, hydroxyurea), radiophosphorus therapy, immunomodulatory drug therapy (eg, interferon-alpha), corticosteroids >10 mg/day prednisone or equivalent or anagrelide within 14 days prior to initiation of study drug
- •Active malignancy other than PV or ET, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for =5 years.
- •Major surgery within 28 days or radiation within 3 months prior to initiation of study drug.
- •Unable to swallow capsules.
- •Active acute infection requiring antibiotics.
- •Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
- •Clinically active hepatitis B or C.
- •Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- •Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator’s opinion, would make the patient inappropriate for entry into this study.
- •Inadequate organ function
- •Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4, unless approved by the Sponsor.
- •Presence of any gastric or other disorder that would inhibit absorption of oral medication.
- •Known hypersensitivity to any excipients in the study drug formulation
- •Pregnant or lactating female.
- •Women of childbearing potential, unless using effective contraception while on study drug.
- •Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug.
研究者
相似试验
进行中（未招募）
不适用
Study with SAR302503 in polycythemia vera or essential thrombocythemiapolycythemia vera, or essential thrombocythemiaMedDRA version: 14.0Level: LLTClassification code 10018864Term: Haematopoietic neoplasm NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001847-58-ESsanofi-aventis recherche & développement90
进行中（未招募）
不适用
Study with SAR302503 in polycythemia vera or essential thrombocythemiapolycythemia vera, or essential thrombocythemiaMedDRA version: 14.1Level: HLGTClassification code 10018865Term: Haematopoietic neoplasms (excl leukaemias and lymphomas)System Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-001847-58-ITSANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT90
进行中（未招募）
1 期
Study with SAR302503 in polycythemia vera or essential thrombocythemiaEUCTR2011-001847-58-GBsanofi-aventis recherche & développement81
进行中（未招募）
1 期
A Phase 2, Open-Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19Subjects with life-threatening COVID-19 symptomsMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001644-25-DEAcerta Pharma B.V.177
进行中（未招募）
1 期
A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19Subjects with life-threatening COVID-19 symptomsEUCTR2020-001644-25-ITACERTA PHARMA BV140