EUCTR2015-003007-38-CZ进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy - ATLAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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
- •- Age >= 18 years
- •- Indicated and planned to receive primary radiation therapy for prostate cancer
- •- Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis:
- •1) Gleason score >=8 and >=cT2c stage per AJCC 8th Edition
- •2) Gleason score 7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c stage per AJCC 8th Edition
- •- Charlson comorbidity index (CCI) <=3
- •- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
- •- Adequate organ function determined by the following central laboratory values:
- •1) aspartate aminotransferase (AST), alanine aminotransferase (ALT) within normal limits (WNL)
- •2) total bilirubin (WNL)
- •3) Serum creatinine <1.5 mg/dL (<133 µmol/L)
- •4) Platelets =140,000/µL, independent of transfusion and/or growth factors within 3 months prior to randomization
- •5) Hemoglobin = 12.0 g/dL (7.4 mmol), independent of transfusion and/or growth factors within 3 months prior to randomization
- •- Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
- •- Signed, written, informed consent
- •- Be able to swallow whole study drug tablets
- •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 1470
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Presence of distant metastasis (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
- •- Prior treatment with GnRH analogue or antiandrogen or both for >3 months prior to randomization
- •- Bilateral orchiectomy
- •- History of pelvic radiation
- •- Prior systemic (eg, chemotherapy) or local (eg, radical prostatectomy, cryotherapy) treatment for prostate cancer
- •- History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as
- •schwannomas and meningiomas that are causing edema or mass effect)
- •- Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
- •- Prior treatment with radiopharmaceutical agents (eg, strontium 89) or immunotherapy (eg, sipuleucel-T) for prostate cancer
- •- Prior treatment with systemic glucocorticoids =4 weeks prior to randomization or subject is expected to require long-term use of corticosteroids during the study
- •- Use of 5-alpha reductase inhibitors (eg, dutasteride, finasteride) <=4 weeks prior to randomization
- •- Use of any investigational agent <=4 weeks prior to randomization
- •- Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for non-oral
- •formulations
- •- Major surgery <=4 weeks prior to randomization
- •- Current or prior treatment with antiepileptic medications for the treatment of seizures
- •- Gastrointestinal conditions affecting absorption
- •- Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
- •- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
研究者
相似试验
进行中（未招募）
1 期
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Alcoholic hepatitisEUCTR2020-004534-38-DEDURECT Corporation300
进行中（未招募）
不适用
A Clinical Trial Investigating OSI-906 in Patients with Adrenocortical CarcinomaAdrenocortical CarcinomaMedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-012820-97-DEAstellas Pharma Global Development, Inc.135
招募中
3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast CancerBreast carcinoma10006291Breast cancerNL-OMON51870Merck Sharp & Dohme (MSD)24
进行中（未招募）
不适用
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersEUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
进行中（未招募）
1 期
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282