EUCTR2012-000136-26-IE进行中（未招募）不适用
A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1. Voluntary written consent.
- •2. Patients must have a diagnosis of mCRPC.
- •3. Screening PSA = 2 ng/mL.
- •4. Prior surgical or medical castration with testosterone at screening < 50 ng/dL.
- •5. Eastern Cooperative Oncology Group performance status of 0 or 1.
- •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 10
排除标准
- •1. Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.).
- •2. Documented central nervous system metastases.
- •3. Clinically significant heart disease.
- •4. Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS>110 ms, QTcF>450ms, PR interval>200 ms
- •5. Patients who have a history of risk factors for TdP including unexplained syncope, known long QT syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments.
- •Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- •Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
研究者
相似试验
进行中（未招募）
1 期
Study to find out whether treatment with orteronel plus prednisone has any potential effects on the heart, by looking at certain heart waves, called QT waves, using an electrocardiogram (ECG) machine.metastatic castration-resistant prostate cancer (mCRPC)MedDRA version: 15.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000136-26-FRMillennium Pharmaceuticals, Inc.50
进行中（未招募）
不适用
Study to find out whether treatment with orteronel plus prednisone has any potential effects on the heart, by looking at certain heart waves, called QT waves, using an electrocardiogram (ECG) machine.metastatic castration-resistant prostate cancer (mCRPC)MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000136-26-GRMillennium Pharmaceuticals, Inc.40
进行中（未招募）
1 期
Effect of patiromer in children under 12 years of age with high blood potassium levelsMedDRA version: 21.1Level: LLTClassification code: 10020647Term: Hyperkalemia Class: 10027433HyperkalemiaCTIS2023-505252-21-00Vifor Pharma Inc.36
Unknown
2 期
Patiromer for treatment of hyperkalaemia in children from birth to <6 years of ageHyperkalaemiahyperkalaemiaE87.5LBCTR2023055223Vifor Pharma, Inc.21
已完成
1 期
A Phase 1b, Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Healthy Volunteers Aged 50-85Dry Age related macular degeneration (AMD)Eye - Diseases / disorders of the eyeACTRN12622001520729RBP4 Pty Ltd15