EUCTR2013-001876-39-DE进行中（未招募）1 期
An open-label phase IIb study to evaluate the safety, tolerability and efficacy of Fotolon® as a photosensitising agent for the local treatment of airway-obstructing non small cell lung cancer (NSCLC) with photodynamic therapy (PDT)
Apocare Pharma GmbH0 个研究点目标入组 15 人开始时间: 2014年3月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •1. Male and female patients aged ? 18 years.
- •2. Patients with histologic confirmed NSCLC with completely or partially obstructing endobronchial lesions with or without extrabronchial tumor requiring therapy and amenable to bronchoscopic intervention.
- •3.Patients with tumors, which were already treated with a first line therapy (e.g. chemotherapy), having recurrent, therapy resistant or inoperable tumors.
- •4.Patients presenting with pulmonary symptoms attributable to the endobronchial lesion (e.g. dyspnea, cough, hemoptysis, retention pneumonia).
- •5.Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status ?2 at study entry.
- •6.Patients with an anticipated life expectancy of at least 3 months .
- •7.Patients with an adequate hematologic capacity, defined by
- •- WBC ? 3.5 x 109 / l
- •- Platelets ? 150 x 109 / l
- •- Hemoglobin ? 10 g / dl.
- •8.Patients with adequate liver function, defined by
- •- serum bilirubin ? 2.0 mg / dl
- •- SGOT, SGPT, GGT ? 3 times ULN.
- •9.Patients with adequate renal function, defined by
- •- serum creatinine ? 1.5 mg / dl or
- •- creatinine clearance ? 60 ml/min.
- •10.Prothrombin time ? 1.5 x ULN
- •11.Complete recovery from relevant toxicities of any prior treatment.
- •12.Effective contraception for women of childbearing potential (< 1% failure rate, combination pill and condom) and for men.
- •13.Patients must be alert and able to willingly give informed consent.
- •14.Patients must have given their written informed consent to participate in this study after fully understanding the implications and constraints of the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Women who are pregnant or breast feeding.
- •2.Women of child-bearing potential not under adequate contraceptive protection (>1% failure rate) and men not executing contraceptive protection.
- •3.Patients with clinically relevant infection.
- •4.Past or current history of another malignant disease which has not been curatively treated and has been without evidence of disease for less than 3 years, except non-melanoma skin cancer and in situ carcinoma of the cervix.
- •5.Porphyria or hypersensitivity against porphyrins or other diseases known to be exacerbated by light.
- •6.Hypersensitivity to Fotolon® or to any of the excipients of the study medication.
- •7.Tumors with known or suspected erosion of major blood vessel in or adjacent to the illumination area.
- •8.Patients with thoracic radiotherapy within the last 4 weeks prior to inclusion in the study.
- •9.Patients with chemotherapy (including radiochemotherapy) within the last 4 weeks prior to inclusion in the study (Mitomycin C or Nitrosureas: 6 weeks).
- •10.Patients who have had thoracic surgery within the last 4 weeks.
- •11.Patients who had other surgery within the last 2 weeks, unless fully recovered.
- •12.Therapy with another photosensitizing agent in parallel or during the last 4 weeks.
- •13.Coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
- •14.Patients with known CNS metastases coming along with neurologic signs or symptoms.
- •15.Patients with psychiatric or other disorders that would interfere with their ability to give written informed consent.
- •16.Patients who are unable or unwilling to meet the requirements of the protocol.
- •17.Patients with a known history of drug, medication or alcohol abuse.
- •18.Patients participating in another study with an investigational medicinal product within less than one month prior to inclusion in the study.
- •19.Patients with any other condition which is considered by the investigator to bear a high risk of interfering with the drug medication.
研究者
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