Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

Official title:

Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177668
• Other study ID #: YS1101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 8, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: September 2020
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma

Intervention

Drug:
• YS110
Intravenous administration

Locations

Country	Name	City	State
Japan	Research Site	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of onset of Dose Limiting Toxicity (DLT)	Assessed by number of subjects with DLT of YS110	18 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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