NL-OMON53969已完成3 期
An open-label, multicentre, single arm study to assess the efficacy and safety of triptorelin 6-month formulation administered subcutaneously in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a GnRH analogue - TriptoSwitch
Ipsen Pharmaceuticals0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
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
- 18 至 99（—）
入选标准
- •1. Participant is male and must be 18 years of age inclusive, at the time of
- •signing the informed consent.
- •2. Participant has histologically or cytologically proven prostate cancer with
- •rising PSA after failed local therapy or metastatic disease, or requiring
- •radiotherapy, and be a candidate for long-term (i.e. >1 year) androgen
- •deprivation therapy.
- •3. Participant requires a GnRH analogue treatment for a minimum of 18 months,
- •of which a minimum of 3 months of GnRH analogue treatment has already been
- •provided prior to screening. (Note: participants must receive study
- •intervention on Day 1 in accordance with the treatment schedule of their
- •previously received GnRH analogue therapy).
- •4. Has serum testosterone levels <1.735 nmol/L (50 ng/dL) at screening.
- •5. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0
- •to 1 (see Appendix 10.4).
- •6. Has a life expectancy of >18 months.
- •7. Male participants must agree that, if their partner is at risk of becoming
- •pregnant (although highly unlikely in this study population), they will use an
- •effective method of contraception. The participant must agree to use the
- •contraception during the whole of the study and for 9 months after the last
- •dose of study intervention.
- •8. Capable of giving signed informed consent as described in Appendix 10.1
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent form (ICF) and in this protocol
排除标准
- •Medical conditions
- •1.Presence of another neoplastic lesion or brain metastases.
- •2.Metastatic hormone-sensitive prostate cancer with high tumour burden
- •3.Metastatic castration-resistant prostate cancer
- •4.Any concomitant disorder or resulting therapy that is likely to interfere
- •with participant compliance or with the study in the opinion of the
- •investigator.
- •Prior/concomitant therapy
- •5.Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the
- •past 6 months
- •6.Planned intermittent scheme of GnRH analogue
- •7.Use of any other therapy for prostate cancer during the study (e.g.
- •chemotherapy)
- •8.Prior hypophysectomy or adrenalectomy
- •Prior/concurrent clinical study experience
- •9.Participation in another study with an experimental drug within 3 months
- •before signing informed consent or within five half-lives of the
- •investigational drug (whichever was the longer), or any other type of medical
- •Diagnostic assessments
- •10.Severe kidney or liver failure (creatinine >2 times the normal range,
- •aspartate aminotransferase and alanine aminotransferase >3 times the normal
- •Other exclusions
- •11.Any concomitant disorder or resulting therapy that is likely to interfere
- •with participant*s compliance, the subcutaneous administration of the drug or
- •with the study in the opinion of the investigator.
- •12.Previous history of QT prolongation or concomitant use of medicinal products
- •known to prolong the QT interval or with a known risk of torsades de pointes
- •13.Known hypersensitivity to triptorelin or any of its excipients, GnRH, other
- •GnRH agonist/analogues.
- •14.Known active use of recreational drug or alcohol dependence in the opinion
- •of the investigator
- •15.Inability to give informed consent or to comply fully with the protocol.
研究者
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