跳至主要内容
临床试验/EUCTR2015-004433-26-GB
EUCTR2015-004433-26-GB进行中(未招募)1 期

Zoledronic acid in the management of malignant pleural mesothelioma - a feasibility study - ZOL-A trial

orth Bristol NHS Trust0 个研究点目标入组 22 人开始时间: 2016年3月17日最近更新:
适应症
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
22

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

入选标准

  • -Histo-cytologically confirmed diagnosis of MPM
  • -WHO performance status 0-1
  • -Eligible for first line chemotherapy treatment
  • -Measurable disease on CT as per modified RECIST criteria (tumour thickness >5mm)
  • -Ability to give informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 45

排除标准

  • Not fit for chemotherapy due to performance status or other comorbidities
  • Previous chemotherapy for MPM
  • IV bisphosphonates in the 3 months preceding randomisation
  • Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
  • Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests – should be within the last 6 weeks)
  • Known allergy to bisphosphonates or excipients of its preparation
  • Severe untreated dental caries
  • Concomitant participation in another drug trial for mesothelioma
  • Allergy to 18-Fluodeoxyglucose used for the PET scan
  • Women of child bearing potential (defined as fertile, or following menarche and until becoming post-menopausal unless permanently sterile)

研究者

发起方
orth Bristol NHS Trust

相似试验