Malignant pleural mesothelioma
Conditions
Interventions
investigational material(s)
Generic name etc : Ad-SGE-REIC
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mater
Sponsors
Kyorin Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologic diagnosis of malignant pleural mesothelioma -Patients must have measurable lesions, which are diagnosed. -Patients refractory to the chemotherapy including pemetrexed or Patients who cannot undergo chemotherapy, Patients who refuse the systemic chemotherapy for malignant pleural mesothelioma. -ECOG Performance status score: 0 - 2 -Prior radiotherapy must be completed at least 4 weeks before study enrollment, and the patients must have recovered from the toxic effects of the treatment prior to case entry. -If chemotherapy was performed before study enrollment, prior chemotherapy must be completed at least 4 weeks and the patients must have recovered from the toxic effects of the treatment prior to case entry. -Patients who have adequate main organs function - Patients expected to be alive for at least 12 weeks before study enrollment , etc.
Exclusion criteria
Exclusion criteria: -Patients with recurrent malignant pleural mesothelioma after surgical therapy or Patients with pneumonectomy due to the disease other than malignant pleural mesothelioma -Patients with simultaneous tumor and/or metachronaus tumor (excluding patients with them whose disease-free interval is over 2 years) -Patients with brain metastasis -Patients who have received prior any gene therapies and immunotherapies , etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability Frequency of DLT, etc | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor effectiveness, etc Objective response rate, disease control rate, etc | — |
Outcome results
None listed