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Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

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.

Tracking Information
First Received DateMay 23, 2017
Last Changed DateJune 2, 2017
Start DateJune 2017
Anticipated Primary Completion DateDecember 2020
Primary Outcome Measures

Status of onset of Dose Limiting Toxicity (DLT) [Time Frame: 18 days]

Disease Control Rate (DCR) [Time Frame: 6 months]

Progression Free Survival (PFS) [Time Frame: Assessed for duration of study participation which is estimated to be 18 months]

Response Rate (RR) [Time Frame: Assessed for duration of study participation which is estimated to be 18 months]

Overall Survival (OS) [Time Frame: Assessed for duration of study participation which is estimated to be 18 months]

LCSS-Meso [Time Frame: Assessed for duration of study participation which is estimated to be 18 months]

EORTC QLQ-C30 [Time Frame: Assessed for duration of study participation which is estimated to be 18 months]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Drug: YS110
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment48
GenderAll
Ages20 Years - N/A
Accepts Healthy VolunteersNo
Contact Kissei Pharmaceutical Co., Ltd
Email: rinsyousiken@pharm.kissei.co.jp
Phone: (Email only)
Eligibility Criteria

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

Administrative Information
NCTIDNCT03177668
Responsible Party,
SponsorKissei Pharmaceutical Co., Ltd.
Verification DateJune 2017
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