NCT00127478已完成2 期
A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 166
- 试验地点
- 28
- 主要终点
- Adverse events
研究概览
简要总结
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 18 years, inclusive;
- •Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
- •Karnofsky Performance Score greater than or equal to 60;
- •Adequate hematologic function and liver function tests;
- •No New York Heart Association (NYHA) class greater than or equal to 2.
排除标准
- 未提供
结局指标
主要结局
Adverse events
时间窗: Every 12 weeks
Serious adverse events
Oncology-related events (OREs)
Deaths
Study drug exposure
Change from baseline in Karnofsky performance status
Vital signs
Stratification by treatment group from prior study
次要结局
- Safety and laboratory parameters(Every 12 weeks)
研究者
研究点 (28)
Loading locations...
相似试验
终止
3 期
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)Idiopathic Parkinson DiseaseParkinson DiseaseNCT01215227Merck Sharp & Dohme LLC839
已完成
2 期
Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)Duchenne Muscular DystrophyNCT00758225Santhera Pharmaceuticals21
已完成
2 期
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac AmyloidosisTTR-mediated AmyloidosisNCT02292186Alnylam Pharmaceuticals25
已完成
2 期
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) MyopathyGNE MyopathyHereditary Inclusion Body Myopathy (HIBM)NCT01830972Ultragenyx Pharmaceutical Inc59
已完成
3 期
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831Schizophreniform DisorderSchizophreniaBipolar I DisorderNCT03201757Alkermes, Inc.524