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临床试验/NCT02311764
NCT02311764终止2 期

Single Arm Open Label Phase II Pilot Study of Carboplatin in Patients With Metastatic Castrationresistant Prostate Cancer (CRPC) and PTEN Loss and/or DNA Repair Defects

Aurelius Omlin3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年2月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
16
试验地点
3
主要终点
Response
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Open label, non-randomised phase II clinical pilot study

详细描述

Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •Written Informed Consent
  • •Adult patients with histological diagnosis of adenocarcinoma of the prostate.
  • •Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • •Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
  • •DNA repair defects as per central assessment
  • •Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
  • •Progression of disease by any of the criteria listed here:
  • •PSA utilizing PCWG 2 criteria
  • •Bone scan
  • •RECIST 1.1
  • •Adequate organ and bone marrow function as evidenced by:
  • •Haemoglobin ≥8.0 g/dL
  • •Absolute neutrophil count ≥1.5 x 109/L
  • •Platelet count ≥ 100 x 109/L
  • •AST and/or ALT < 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT <5 x ULN
  • •Total bilirubin < 2.0 x ULN (except for patients with Gilbert's disease)
  • •Creatinine Clearance ≥30ml/min
  • •Patient must agree in the biomarker studies including the fresh tumour biopsies

排除标准

  • •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
  • •Prior treatment with any prior platinum based chemotherapy,
  • •Major surgery within 4 weeks prior to planned start of treatment
  • •Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
  • •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • •Previous enrolment into the current study
  • •Active secondary malignancy that requires systemic therapy.

研究组 & 干预措施

Carboplatin

Experimental

Carboplatin will be administered weekly

干预措施: Carboplatin (Drug)

结局指标

主要结局

Response

时间窗: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months

Soft tissue or PSA Response

次要结局

  • OS(Time Frame: livelong follow-up)
  • Safety as per CTC AEv4.03(on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months)
  • PTEN loss(Pre-study biopsy sample)
  • Rate of PSA declines of ≥30%(Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months))
  • rPFS(Time Frame: Up to the end of the treatment phase (ie, approximately 6 months)
  • PSA(on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months)
  • Disease control rate(On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months)

研究者

发起方
Aurelius Omlin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aurelius Omlin

MD

Cantonal Hospital of St. Gallen

研究点 (3)

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