EUCTR2011-001897-25-ES进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
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 Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
- •MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria.
- •Enlarged spleen, palpable at least 5 cm below costal margin.
- •At least 18 years of age.
- •Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
- •The following laboratory values within 14 days prior to the initiation of IMP or placebo:
- •Absolute Neutrophil Count (ANC) ?1.0 x 10exp9/L
- •Platelet count ?50 x 10exp9/L
- •Serum creatinine ?1.5 x Upper Limit of Normal (ULN)
- •Serum amylase and lipase ?1.5 x ULN
- •Direct bilirubin ?2.0 x ULN
- •Aspartate aminotransferase or alanine aminotransferase ?3 x ULN; higher values (ie, ?5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis.
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
排除标准
- •Splenectomy.
- •Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
- •Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
- •Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of bimekizumab compared to placebo and an active comparator in adult subjects with moderate to severe chronic plaque psoriasisModerate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-003425-42-ITCB Biopharma SR567
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 16.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-HUAmgen Inc450
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis - CIMPACTMedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000018190Plaque PsoriasisEUCTR2014-003492-36-GBCB Biopharma, SPR561
进行中（未招募）
1 期
Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Diseasemoderately to severely active Crohn’s diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2018-004614-18-SKEli Lilly and Company1,150
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction CancerAdvanced MET-Positive Gastric, Lower Esophageal or Gastroesophageal Junction AdenocarcinomaMedDRA version: 17.0Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017761Term: Gastric cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10017766Term: Gastric cancer stage IV NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004923-11-BGAmgen Inc600