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临床试验/CTRI/2017/10/010219
CTRI/2017/10/010219尚未招募2 期

Pazopanib based combination oral metronomic therapy in platinum resistant, platinum refractory and advanced ovarian cancer : A Randomized Phase 2 Study

Aparna Sharma0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
尚未招募
发起方
研究概览入排标准研究者记录与标识符相似试验

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

入选标准

  • •a.Written Informed consent by all study participants
  • •b.Female subjects > 18 years of age with histologically confirmed diagnosis of epithelial ovarian cancer which is platinum resistant, platinum refractory, Or advanced (Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting).
  • •c.Patients must have failed available standard chemotherapy regimen (except if medically contraindicated or refused by the patient)
  • •d.Performance status ECOG 0-2
  • •e.Adequate organ functions
  • •i.Adequate bone marrow function (e.g. platelets > 100 x 109/L, ANC > 1.5 x 109/LHb >10gm%)
  • •ii.Adequate liver function (e.g. ALT/AST < 1.5 x ULN, serum bilirubin <2mg%)
  • •iii.Adequate renal function (e.g. creatinine clearance > 50 ml/min)
  • •iv.Adequate cardiac function (e.g. LVEF >40%)
  • •f.Able to swallow and retain oral medication
  • •g.A life expectancy of at least 12 weeks

排除标准

  • •a.Age <=18 years at initial diagnosis
  • •b.Patients not willing to consent for the study
  • •c.ECOG Performance status 3 and 4
  • •d.Active infection (pneumonia etc.)History of Uncontrolled hypertension ,ischemic event or clinical evidence of thrombo-embolic event
  • •e.History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6months
  • •f.Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
  • •g.Any other organ dysfunction (CTCAE Grade 4)

研究者

发起方
Aparna Sharma

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