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Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Primary Purpose

Malignant Pleural Mesothelioma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
YS110
Sponsored by
Kissei Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YS110

Arm Description

Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part

Outcomes

Primary Outcome Measures

Status of onset of Dose Limiting Toxicity (DLT)
Assessed by number of subjects with DLT of YS110
Disease Control Rate (DCR)
The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Progression Free Survival (PFS)
The period from the starting day of the administration to Progressive Disease (PD) or death
Response Rate (RR)
The proportion of subjects with assessed the best overall response as CR or PR
Overall Survival (OS)
The period from the starting day of the administration to death
LCSS-Meso
Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
EORTC QLQ-C30
Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients

Secondary Outcome Measures

Full Information

First Posted
May 23, 2017
Last Updated
September 23, 2020
Sponsor
Kissei Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03177668
Brief Title
Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Official Title
Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YS110
Arm Type
Experimental
Arm Description
Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part
Intervention Type
Drug
Intervention Name(s)
YS110
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Status of onset of Dose Limiting Toxicity (DLT)
Description
Assessed by number of subjects with DLT of YS110
Time Frame
18 days
Title
Disease Control Rate (DCR)
Description
The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
Time Frame
6 months
Title
Progression Free Survival (PFS)
Description
The period from the starting day of the administration to Progressive Disease (PD) or death
Time Frame
Assessed for duration of study participation which is estimated to be 18 months
Title
Response Rate (RR)
Description
The proportion of subjects with assessed the best overall response as CR or PR
Time Frame
Assessed for duration of study participation which is estimated to be 18 months
Title
Overall Survival (OS)
Description
The period from the starting day of the administration to death
Time Frame
Assessed for duration of study participation which is estimated to be 18 months
Title
LCSS-Meso
Description
Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
Time Frame
Assessed for duration of study participation which is estimated to be 18 months
Title
EORTC QLQ-C30
Description
Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients
Time Frame
Assessed for duration of study participation which is estimated to be 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuo Kanai
Organizational Affiliation
Kissei Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Multiple Locations
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

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