EUCTR2017-003549-72-DK进行中（未招募）1 期
Phase II study of Irofulven in AR-targeted and Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer Patients, who have a Drug Response Predictor (DRP™) indicating a high likelihood of response to Irofulven
Oncology Venture Aps0 个研究点目标入组 27 人开始时间: 2017年10月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
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. 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:
- •a.Disease progression after treatment with at least 1 but no more than 2 prior next-generation AR-targeted therapies (abiraterone acetate, enzalutamide, or investigational AR-targeted agent) for metastatic prostate cancer (treatment with the older anti-androgen therapies such as bicalutamide, flutamide, and nilutamide are not counted toward this limit), AND
- •b. Disease progression after treatment with docetaxel for metastatic Prostate cancer. Prior Docetaxel therapy administered for hormone-sensitive disease is permitted and is not counted toward this limit. 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 = 1 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. Drug response predictor (DRPTM) in the upper likelihood of response (DRP value is available via the screening procedure performed by Medical Prognosis Institute)
- •9. 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 (calculated according to the Cockcroft and Gault method)
- •10. Recovered to grade 0 or 1 from any toxic effects of prior chemotherapy, radiotherapy
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •In order to participate in the study subjects must not meet any of the following exclusion criteria:
- •1. Prior external beam radiation therapy to >25% of the bone marrow
- •2. Contraindication to the use of prednisolone (e.g. uncontrolled diabetes mellitus)
- •3. Prior treatment with Irofulven.
- •4. Ongoing treatment with a corticosteroid at a prednisolone-equivalent dose > 10 mg/day
- •5. More than 1 prior treatment with either 153Sm or 89Sr, or radioisotope treatment or treatment with bisphosphonate agents or antibody treatment i.e., denosumab within 2 months prior to initiation of treatment with IMP. Pre-existing treatment with bisphosphonate agents or denosumab is to be continued during the study
- •6. Initiation of treatment with bisphosphonate agents or antibody treatment i.e., denosumab, within 4 weeks of study start. Pre-existing treatment with bisphosphonate agents or denosumab is to be continued during the study
- •7. Treatment with coumarin derivatives and/or phenytoin most be discontinued and coagulation parameters most be within the normal range before treatment with Irofulven
- •8. 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
- •9. Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigator’s discretion)
- •10. History of retinopathy
- •11. Presence of any active infection (at the investigator’s discretion).
- •12. CNS disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures
研究者
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