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 andGemcitabine in Patients with Malignant Pleural Mesothelioma - INFINITE

Trizell Ltd.0 个研究点目标入组 300 人开始时间: 2021年8月3日最近更新: 2021年8月10日

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 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 (if biphasic, histology must be predominantly [>=50%] epithelioid);
•3. Measurable disease, per modified RECIST 1.1 for pleural mesothelioma;
•4. Has received 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 IPC or similar device insertion. Patients with a previously inserted IPC or similar device may enroll, and the pre-existing IPC or similar device 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 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 after the last dose of gemcitabine; Female patients of nonchildbearing potential must be either postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile upon entry into the study;
•- Male patients must be either surgically sterile or agree to use a double barrier contraception method from Screening until 6 months after the last dose of gemcitabine administration;
•- Where available and in accordance with local practice, male patients must be advised to seek further advice regarding cryoconservation of
•sperm prior to gemcitabine treatment due to the possibility of infertility after therapy with gemcitabine; and
•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; Treatment that is split between presurgical
•resection and post-surgical resection and is the same regimen will be counted as 1 regimen. Patients meeting this condition should be discussed with the Medical Monitor prior to including the patient in the study;
•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; Standard of care CT scans completed within 2 weeks prior to Screening may be used in place of the Screening CT scan on a case by-case basis as agreed with the Medical Monitor;
•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 or rAd-IFN (including any of its excipients); ;
•10. Known hypersensitivity to celecoxib (including any of its excipients) or sulfonamides;
•11. Known hypersensitivity to gemcitabine (including any of its excipients);
•12. Impaired cardiac function or clinically significant cardiac disease;
•13. Women who are pregnant or breastfeeding;
•14. Uncontrolled intercurrent illness 15. 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);
•16. History of asthma,acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors;;
•17. History of ulcer disease or gastrointestinal bleeding;
•18. Uncontrolled or poorly controlled hypertension (i.e., blood pressure >160/100 mmHg) requiring 3 or more anti-hypertensive drugs;
•19. Heart rate corrected QT interval using Fridericia's formula >470 ms on resting 12-lead electrocardiogram (ECG);
•20. Patients receiving lithium;
•21. 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;
•22. History of a prior malignancy for which treatment was completed <2 years prior to Screening or for which the patient has continued evidence
•of disease, or concurrent malignancy that is clinically unstable and
•requires tumor-directed treatment;
•23. Has a congenital or acquired immunodeficiency, including patients with known history of infection with human immunodeficiency virus.
•24. Has both serum albumin 2.5 to 3.5 g/dL and total bilirubin >1.5 x ULN;
•25. History of clinically significant inflammatory bowel disease requiring systemic (parenteral) immunosuppressive therapy within 5 years prior to Screening; or
•26. History of galactose intolerance, Lapp lactase deficiency, or glucosegalactose malabsorption.

研究者

发起方

Trizell Ltd.

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