DRKS00003495尚未招募2 期
Treatment of patients with metastatic melanoma (AJCC stage IV or III unresectable) with the PDE-inhibitor Tadalafil:A Pilot Trial for Proof of Principle” - TaMe
niversitätsklinikum Heidelberg0 个研究点目标入组 12 人开始时间: 2012年1月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •a) Histologically proven metastatic melanoma
- •b) Clinical stage IV or III unresectable (AJCC 2010)
- •c) = 18 to 75 years of age
- •d) Presence of cutaneous or accessible lymph node metastases (tumor biopsies)
- •e) Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with at least one diameter = 5 mm and the other dimension = 5 mm assessed by ultrasound)
- •f) ECOG performance status of 0-2
- •g) At least one prior treatment for metastatic disease, including established treatments like Ipilimumab.
- •h) No medical contraindication to biopsy of target lesion.
- •i) Willingness and ability to understand the informed consent and the quality of life questionnaires and to give signed written informed consent.
- •j) Women of childbearing potential must agree to use effective contraception during the study.
排除标准
- •a) Any evidence of brain metastases
- •b) Patients with severe cardiac disease (e.g. NYHA Functional Class II, III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris, sinusbradycardia).
- •c) Concurrent medication with nitrates, alpha-Blockers e.g. Doxazosin or other interacting medications (CYP3A4 inhibitors e.g. Ketoconazole, Erythromycin, Clarithromycin, Intraconazol and grape fruit juice, CYP3A4 inductors e.g. Rifampicin, Phenobarbital, Phenytoin and Carbamazepin)
- •d) Uncontrolled blood pressure (<90/50mm Hg or uncontrolled hypertone)
- •e) laboratory data (to be obtained within 4 weeks of initiation):
- •Platelets < 75,000/mm³
- •Calculated Creatinine Clearance (CRCL) < 60 ml/min
- •ALAT or ASAT > 2 x ULN
- •Total serum bilirubin > 1.5 mg/dl
- •f) Patients who have a history of depression requiring hospitalization
- •g) Patients with seizure disorders requiring anticonvulsant therapy
- •h) Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- •i) History of ischemic neuropathy of the optical nerve (NAION)
- •j) Brain insult within the last 6 months
- •k) Anatomic penis deformation or history of priapismus or predisposing illness like sickle cell anemia or hyperglobulinaemia
- •l) Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds five years.
- •m) Concurrent treatment with other anti-cancer therapy or parallel participation in another therapeutic trial
- •n) Known hypersensitivity reaction to Tadalafil or other ingredients of Cialis®.
- •o) Unwilling or unable to comply with the requirements of the protocol
- •p) Pregnant or lactating women
- •q) Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment
研究者
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