EUCTR2017-003169-82-FR进行中（未招募）1 期
A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma - INFINITE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Trizell Ltd
- 入组人数
- 300
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. Aged 18 years or older and able to give informed consent;
- •2. Confirmed histological diagnosis of MPM with histological type epithelioid or biphasic (predominantly [>=50%] epithelioid);
- •3. Measurable disease, per modified RECIST for pleural mesothelioma;
- •4. Has failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, which may have been chemotherapeutic and/or immunotherapeutic treatment regimens for MPM which included at least 1 anti-folate and platinum combination regimen;
- •5. Has a pleural space accessible for pleural catheter insertion. Patients with a previously inserted pleural catheter may enroll, and the pre-existing catheter can be used for vector administration as long as it is functional and has no evidence of local infection;
- •6. Life expectancy >=12 weeks in the judgement of the Investigator;
- •7. ECOG status of 1 or 0;
- •8. Female and male patients:
- •- Female patients must be either postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile upon entry into the study. Female patients of childbearing potential must have a negative pregnancy test upon entry into this study and agree to use a highly effective method of contraception from Screening until 1 month following administration of gemcitabine;
- •- Male patients must be either surgically sterile or agree to use a double-barrier contraception method from Screening until 1 month post-gemcitabine administration;
- •9. Adequate laboratory values at screening
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Is treatment-naïve” (i.e., has not received at least 1 anti-folate and platinum combination regimen);
- •2. Has previously received 3 or more lines of systemic chemotherapeutic or immunotherapeutic treatment;
- •3. Has previously received treatment with gemcitabine;
- •4.Has stage IV extrathoracic metastatic disease;
- •5.Inadequate pulmonary function of clinical significance as per Investigator review;
- •6.Clinically significant pericardial effusion at Screening;
- •7.Prior therapy(ies), if applicable, must be completed according to the protocol-specified criteria
- •8.Patient previously treated with IFNs (e.g., for chronic active hepatitis);
- •9.Suspected/known hypersensitivity to IFN-a2b;
- •10. Known hypersensitivity to celecoxib or sulfonamides;
- •11. Impaired cardiac function or clinically significant cardiac disease;
- •12. Women who are pregnant or breastfeeding;
- •13. Uncontrolled intercurrent illness
- •14. Patients with active, known, or suspected auto-immune disease or a syndrome that requires systemic or immunosuppressive agents (oral prednisolone or equivalent at a dose of <=10 mg per day is permitted);
- •15. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs;
- •16. History of ulcer disease or gastrointestinal bleeding;
- •17. Uncontrolled or poorly controlled hypertension requiring 3 or more anti-hypertensive drugs;
- •18. Patients receiving lithium;
- •19. Any significant disease which, in the opinion of the Investigator, would place the patient at increased risk of harm if he/she participated in the study;
- •20. History of malignancy of other organ system within the past 5 years, except treated basal cell or squamous cell carcinoma of the skin, or early stage prostate cancer (stage T2a or smaller, prostate specific antigen <=10 ng/mL, Gleason score <=6); or
- •21. Has a congenital or acquired immunodeficiency, including patients with known history of infection with human immunodeficiency virus.
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