chemotherapy naive and inoperable malignant pleural mesothelioma
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - ECOG Performance status 0 ot 2 - Histologically confirmed malignant pleural mesothelioma which is inoperable - chemotherapy naive (including pre or post operative adjuvant chemotherapy) - Identifiable tumor image present
Exclusion criteria
Exclusion criteria: - History of anti-tumor therapy(chemotherapy, Immunotherapy or biotherapy) - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess in the last 6 months - Clinical symptoms accompanying or treatment requiring metastasis to central nervous system - History of cerebral vascular accident or transient ischemic attack in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other other (Tolerability) CTCAE (ver 4.03) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy CTCAE ver 4.03, RECIST ver 1.1 | — |
Countries
Japan