Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YS110 | Experimental | Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YS110 | Drug | Intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Status of onset of Dose Limiting Toxicity (DLT) | Assessed by number of subjects with DLT of YS110 | 18 days |
| Disease Control Rate (DCR) | The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) | 6 months |
| Progression Free Survival (PFS) | The period from the starting day of the administration to Progressive Disease (PD) or death | Assessed for duration of study participation which is estimated to be 18 months |
| Response Rate (RR) | The proportion of subjects with assessed the best overall response as CR or PR | Assessed for duration of study participation which is estimated to be 18 months |
| Overall Survival (OS) | The period from the starting day of the administration to death | Assessed for duration of study participation which is estimated to be 18 months |
| LCSS-Meso | Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma | Assessed for duration of study participation which is estimated to be 18 months |
| EORTC QLQ-C30 | Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients | Assessed for duration of study participation which is estimated to be 18 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nobuo Kanai | Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Multiple Locations | Japan |
Not provided
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |