A phase II study of Ad-SGE-REIC
- Conditions
- Malignant pleural mesothelioma
- Registration Number
- JPRN-jRCT2080223982
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
The study was discontinued during the study due to below the pre-defined threshold of median PFS for judgement of the efficacy. While there was one subject with a partial response (PR) in the best overall response, there was no overall trend toward tumor reduction with the product. Safety was generally within the expected safety profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 15
Key inclusion criteria
Pathologically confirmed malignant pleural mesothelioma which isunresectable
Patients with one or more measurable disease
ECOG PS<1
Patients who have adequate main organs function
Patients who signed written informed consent
Key exclusion criteria
Patients with simultaneous tumor and/or metachronaus tumor (excluding patients with them whose disease-free interval is over 2 years)
Active infections
Symptomatic brain metastasis requiring treatment
Pulmonary fibrosis or interstitial pneumonia
Cardiac effusion requiring treatment
Comorbidities requiring systemic corticosteroid or an immunosuppressants
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method