EUCTR2019-004259-35-DK进行中（未招募）1 期
Ebastine in combination with docetaxel as a treatment for castration-resistant metastatic prostate cancer
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
- 30
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
- •In order to participate in this study, the subjects must meet all of the following inclusion criteria:
- •1.Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed).
- •2. Surgically or medically castrated, with serum testosterone levels of = 50 ng/dL equivalent to 1.7 nmol/L. For patients, currently being treated with luteinizing hormone–releasing hormone (LHRH) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study.
- •3. Have evidence of disease progression after prior therapy for mCRPC:
- •Disease progression after initiation of most recent therapy is based on any of the following criteria:
- •?Rise in PSA: a minimum of 2 consecutive rising levels, with an interval of = 1 week between each determination. The most recent screening measurement must have been = 2 ng/mL
- •?Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by RECIST 1.1
- •?Radionuclide bone scan: at least 2 new metastatic lesions
- •4. Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
- •5. Age = 18 years
- •6. Life expectancy = 3 months
- •7. Performance status 0 - 1
- •8. Adequate organ functions
- •a. Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L
- •b. Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 UNL, albumin > 25 g/L
- •c. Renal: creatinine clearance >30 mL/min/1.73m2
- •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 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •In order to participate in the study subjects must not meet any of the following exclusion criteria:
- •1. History of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration
- •2. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator’s discretion)
- •3. Presence of any active infection (at the investigator’s discretion).
- •4. CNS disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
- •5.Concurrent use of cationic amphiphilic drugs (see appendix B) including over-the-counter medication.
- •6.Use of other investigational drug
- •7.Allergic reaction to any of the included drugs
研究者
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