Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in the profile and concentration of urinary lipids and blood lipids
研究概览
简要总结
This is an open-label phase I/II study evaluating the addition of ebastine to docetaxel in the treatment for metastatic castration resistant prostate cancer.
Patients will be randomized in a 2:1 fashion to receive ebastine daily during and after treatment with a maximum of 10 courses of docetaxel.
The primary endpoint is change in the profile of urinary and blood lipids to indicate absorption and possible efficacy of ebastine.
Secondary endpoints include PSA response and radiologic progression free survival.
详细描述
The complete study protocol can be studied by contacting the authors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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).
- •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.
- •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
- •Signed informed consent obtained prior to initiation of any study-specific procedures or treatment
- •Age ≥ 18 years
- •Life expectancy ≥ 3 months
- •Performance status 0 - 1
- •Adequate organ functions
- •Hematological: absolute neutrophil count (ANC) >1.5 x 109/L, platelet count >100 x 109/L, hemoglobin > 6,2 mmol/L
- •Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) <2.5 upper normal lever, albumin > 25 g/L
- •Renal: creatinine clearance >30 mL/min/1.73m2
排除标准
- •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
- •Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator's discretion)
- •Presence of any active infection (at the investigator's discretion).
- •Central nervous system (CNS) disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures.
- •Concurrent use of cationic amphiphilic drugs (see appendix A) including over-the-counter medication.
- •Use of other investigational drug
- •Allergic reaction to any of the included drugs
研究组 & 干预措施
Intervention
Standard docetaxel (10 cycles) plus ebastine daily
干预措施: Docetaxel + Ebastine (Drug)
Comparator
Standard docetaxel (10 cycles) without ebastine
干预措施: Docetaxel (Drug)
结局指标
主要结局
Changes in the profile and concentration of urinary lipids and blood lipids
时间窗: Blood+urine samples are collected at baseline, at evaluation scans (after 4th and 7th cycles), and at the end of treatment (after 10 Docetaxel cycles, upon progression before 10 cycles, or at study discontinuation). Each cycle is 21 days.
Measurement of lipid species concentration, focusing on Bis(monoacylglycero)phosphate and lysophospholipids in urine and blood, before, during, and after treatment, compared to PSA levels, radiologic response, and control group results.
次要结局
- radiologic progression-free survival(By comparing with a baseline scan, the treatment effect and disease status will be evaluated with a scan after the 4th and 7th cycles, at end of treatment undtil study completion. Each cycle is 21 days. A patient will receive a maximum of 10 cycles.)
- PSA response(PSA response will be monitored during treatment, compared to radiologic response after the 4th and 7th cycles, and at treatment completion (maximum 10 cycles/progression/discontinuation). Each cycle lasts 21 days)
研究者
Helle Pappot
Professor
Rigshospitalet, Denmark