EUCTR2005-005485-37-IT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-refractory Prostate Cancer - Denosumab 20050147
AMGEN S.P.A.0 个研究点目标入组 1,400 人开始时间: 2006年5月9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
- 1,400
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
- Male
入选标准
- •Inclusion Criteria men with histologically confirmed prostate cancer age .18 years Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 chemical or surgical castration defined as - bilateral orchiectomy also referred to as orchidectomy at least 6 months before randomization, OR - continuous androgen deprivation therapy ADT with a gonadotropin releasing hormone GnRH agonist or antagonist for at least 6 months before randomization total serum testosterone level of 50 ng/dL 1.72 nmol/L hormone refractory androgen independent prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as - 3 consecutive PSA values with PSA1 PSA2 PSA3 - each PSA value must be separated by at least 2 weeks - PSA2 and PSA3 .1.0 ng/mL high risk for development of bone metastasis - PSA value .8.0 ng/mL, obtained no more than 3 months before randomization OR - PSA doubling time .10.0 months calculated per Section 7.8 adequate organ function, as defined by the following criteria - Serum aspartate aminotransferase AST .2.5 x upper limit of normal ULN - Serum alanine aminotransferase ALT .2.5 x ULN - Serum total bilirubin .1.5 x ULN - Serum calcium or albumin-adjusted serum calcium .2.0 mmol/L 8.0 mg/dL and .2.9 mmol/L 11.5 mg/dL before any study-specific procedure, the appropriate written informed consent must be obtained
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria prior or current evidence of radiographically detectable bone metastasis known prior or current evidence of any metastatic involvement of distant organs lymph node metastases in any region is acceptable prior or current IV bisphosphonate administration prior or current use of oral bisphosphonates as follows - greater than or equal to 3 years Page 6 of 98 continuously - greater than 3 months but less than 3 years eligible if subject has a 1 year washout before randomization prior administration of denosumab prior history or current evidence of osteomyelitis or osteonecrosis of the jaw evidence of any of the following conditions per subject self report or medical chart review - any prior malignancy other than treated basal cell skin cancer , within 5 years before randomization - major surgery or significant traumatic injury occurring within 4 weeks before randomization - active infection with Hepatitis B virus or Hepatitis C virus - known infection with human immunodeficiency virus HIV any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results thirty days or less since receiving an investigational product or device in another clinical trial. known sensitivity to any of the products to be administered during the study eg, mammalian derived products, calcium or vitamin D
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108MedDRA version: 6.1Level: PTClassification code 10039073Rheumatoid ArthritisEUCTR2005-003558-83-ITAMGEN S.P.A.784
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2021-002006-27-SIovartis Pharma AG16,500
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2021-002006-27-DKovartis Pharma AG16,500
招募中
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2021-002006-27-ATovartis Pharma AG16,500
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 21.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866EUCTR2021-002006-27-ITOVARTIS PHARMA AG15,000