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

Trizell Ltd0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 撤回
发起方: Trizell Ltd
入组人数: 11

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

年龄范围: 18 至 99（—）

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

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
•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-*2b;
•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.

研究者

发起方

Trizell Ltd

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