A randomised, prospective, open-label, multi-centre study comparing the efficacy and safety of conversion to sirolimus in stable renal or liver transplant recipients with a cutaneous squamous cell carcinoma

Wyeth Pharmaceuticals B.V. (The Netherlands)0 个研究点目标入组 180 人开始时间: 2005年12月19日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Organ (kidney or liver) transplant recipient with biopsy-confirmed cutaneous SCC
•2. Aged over 18 years and at least 12 months post-transplantation
•3. Stable graft function (estimated glomerular filtration rate [GFR] more than 20 ml/min) while on a maintenance regimen with a calcineurin inhibitor, azathioprine, mycophenolate mofetil or steroids for at least 12 weeks before randomisation
•4. No acute rejection episode within 12 weeks prior to randomisation
•5. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomisation. Female patients at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication
•6. Total white blood cell count more than 3000/mm^3, platelet count more than 75,000/mm^3
•7. Fasting triglycerides less than 3.95mmol/l, cholesterol less than 7.8 mmol/l, with or without statins
•8. Signed, dated and witnessed (Institutional Review Board [IRB] or Independent Ethics Committee [IEC] approved) informed consent before screening and before any tests are performed that are specific to the protocol

•1. Metastatic cutaneous SCC
•2. Other malignancies (except for other skin cancers), documented after transplantation
•3. Serum creatinine (for renal allograft recipient) or bilirubin level (for liver allograft recipient) at screening that has increased by more than 30% above the last value obtained at least 12 weeks earlier
•4. Evidence of systemic infection at the time of randomisation
•5. Prior or current use of SRL or any of its derivatives
•6. Use of investigational agents for less than four weeks before randomisation, except for topical dermatological products as Aldara® (imiquimod) or Efudix® (5-fluoro-uracil)
•7. Use of immunosuppressive agents (at the time of randomisation) other than calcineurin inhibitor, azathioprine, mycophenolate mofetil or prednisone
•8. Current use of terfenadine, cisapride, astemizole, pimozide, or cimetidine; these drugs must be discontinued before randomisation
•9. Positive past medical history for documented human immunodeficiency virus (HIV) infection

发起方

Wyeth Pharmaceuticals B.V. (The Netherlands)