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
- Conditions
- Malignant Pleural MesotheliomaMedDRA version: 20.0Level: PTClassification code 10059518Term: Pleural mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003169-82-GB
- Lead Sponsor
- Trizell Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
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 recieved 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
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;
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method