JPRN-jRCTs051220077招募中未知
A multicenter single-arm study assessing efficacy and safety of apalutamide in metastatic castration-resistant prostate cancer patients - GENESIS
akano Yuzo0 个研究点目标入组 110 人开始时间: 2022年8月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •(1) Patients who have histologically significant adenocarcinoma
- •(2) Patients who have 1 or more distant metastases
- •(3) Patients who received any one of the following treatments for hormone-sensitive cancer
- •-Androgen ablative therapy including combined androgen blockade therapy
- •-Combination therapy with androgen ablative therapy and abiraterone
- •-Combination therapy with androgen ablative therapy and docetaxel
- •(4) Patients who were diagnosed as mCRPC, based on at least 1 of the following criteria, in castrate level of blood testosterone < 50 ng/dL after androgen ablative therapy
- •-PSA level >= 1 ng/mL that has increased on 2 successive occasions at least 1 week apart
- •-Appearance of 2 or more new lesions in bone
- •-Nodal or visceral metastases as defined by RECIST 1.1 with PCGW3 modifications
- •(5) Laboratory requirements within 2 months before enrollment
- •AST <= 100 U/L, ALT <= 100 U/L, Serum creatinine <= 2.00 mg/dL
- •(6) ECOG Performance Status 0-2
- •(7) 20 years or over patients
- •(8) Patients who provided informed consent for participation in this study
排除标准
- •(1) Patients who have histologically significant neuroendocrine differentiation or small cell
- •(2) Patients who have received apalutamide, enzalutamide or darolutamide for metastatic prostate cancer or non-mCRPC
- •(3) Patients who received local therapy (total prostatectomy or definitive radiotherapy) within 1 year before enrollement
- •(4) Patients with serious viral active infection
- •(5) Patients who have a history of malignant tumors considered not cured other than prostate cancer
- •(6) Patients suffering from other severe acute or chronic diseases
- •(7) Patients complicated with psychiatric disordersor symptoms and considered difficult to participate in this study
- •(8) Patients found to be intolerable to components of test drug (or excipients)
- •(9) For other reasons, patients who are cosidered inappropriate for participation in this study at physician's discretion
研究者
相似试验
尚未招募
不适用
A single arm, Multicenter study evaluating efficacy of beta 2-microglobulin adsorption column on dialysis-related amyloidosisEnd-stage renal disease, Dialysis-related amyloidosisJPRN-UMIN000031418Hirosaki University School of Medicine30
招募中
1 期
Desensitisation with imlifidase prior to kidney transplant in highly sensitised childreHighly sensitised paediatric patients with a positive crossmatch against a living or deceased donor kidney.MedDRA version: 20.0Level: PTClassification code: 10023439Term: Kidney transplant rejection Class: 100000004870CTIS2022-500230-28-00Hansa Biopharma AB8
进行中（未招募）
1 期
A study to about blinatumomab for patients with minimal residual disease (MRD) of acute lymphoblastic leukemiaPatients with minimal residual disease (MRD) positive B-precursor ALL with and without prior SCT documented after an interval of at least 8 days from last systemic chemo-therapy• at a level of =10-4 - <10-3 (molecular failure or molecular relapse) in an assay with a minimum sensitivity of 10-4 OR• at levels below 10-4 :o Positive <10-4, non quantifiable (MolNE1) ORo Positive <10-4 (MolNE2) OR• Presence of minimal residual disease (MRD), non quantifiable (MolNE3).MedDRA version: 21.1Level: LLTClassification code 10066104Term: Precursor B-lymphoblastic leukaemia acuteSystem Organ Class: 100000004864EUCTR2015-000733-76-DEGoethe-Universität Frankfurt, Universitätsklinikum, Med. Klinik II80
尚未招募
2 期
Clinical Study of BabyOrgano toothpaste.CTRI/2024/07/071262atureovedic Consumers Private Limited
招募中
2 期
Vachadi Ghrita in the management of Karshya vyadhi (underweight) in childrenCTRI/2023/03/050295Dr Vaibhav Subhash Mhaske