Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

NCT ID: NCT03177668

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2020-02-05

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Pleural Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YS110

Phase 1 part: Administration of 3 different dose cohort

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

Group Type EXPERIMENTAL

YS110

Intervention Type DRUG

Intravenous administration

Interventions

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YS110

Intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuo Kanai

Role: STUDY_DIRECTOR

Kissei Pharmaceutical Co., Ltd.

Locations

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Research Site

Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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YS1101

Identifier Type: -

Identifier Source: org_study_id

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