Malignant Pleural Mesothelioma
Conditions
Brief summary
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.
Interventions
DRUGYS110
Intravenous administration
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with male or female aged ≥ 20 (and aged \< 75 in Phase 1 part) * Patients whose malignant pleural mesothelioma was histologically confirmed * Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized * Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less
Exclusion criteria
* Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored * Patients with tumor lesions in central nervous system confirmed in MRI or CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 | Assessed for duration of study participation which is estimated to be 18 months | Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients |
| LCSS-Meso | Assessed for duration of study participation which is estimated to be 18 months | Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma |
| Status of onset of Dose Limiting Toxicity (DLT) | 18 days | Assessed by number of subjects with DLT of YS110 |
| Disease Control Rate (DCR) | 6 months | The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) |
| Progression Free Survival (PFS) | Assessed for duration of study participation which is estimated to be 18 months | The period from the starting day of the administration to Progressive Disease (PD) or death |
| Response Rate (RR) | Assessed for duration of study participation which is estimated to be 18 months | The proportion of subjects with assessed the best overall response as CR or PR |
| Overall Survival (OS) | Assessed for duration of study participation which is estimated to be 18 months | The period from the starting day of the administration to death |
Countries
Japan
Outcome results
None listed