NCT03177668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

May 23, 2017

Last Update Submit

September 23, 2020

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (7)

  • Status of onset of Dose Limiting Toxicity (DLT)

    Assessed by number of subjects with DLT of YS110

    18 days

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

YS110

EXPERIMENTAL

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

Drug: YS110

Interventions

YS110DRUG

Intravenous administration

YS110

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nobuo Kanai

    Kissei Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 6, 2017

Study Start

August 8, 2017

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

JP(1)