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Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03177668
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE June 6, 2017
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE August 4, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • Status of onset of Dose Limiting Toxicity (DLT) [ Time Frame: 18 days ]
    Assessed by number of subjects with DLT of YS110
  • Disease Control Rate (DCR) [ Time Frame: 6 months ]
    The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
  • Progression Free Survival (PFS) [ Time Frame: Assessed for duration of study participation which is estimated to be 18 months ]
    The period from the starting day of the administration to Progressive Disease (PD) or death
  • Response Rate (RR) [ Time Frame: Assessed for duration of study participation which is estimated to be 18 months ]
    The proportion of subjects with assessed the best overall response as CR or PR
  • Overall Survival (OS) [ Time Frame: Assessed for duration of study participation which is estimated to be 18 months ]
    The period from the starting day of the administration to death
  • LCSS-Meso [ Time Frame: Assessed for duration of study participation which is estimated to be 18 months ]
    Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma
  • EORTC QLQ-C30 [ Time Frame: Assessed for duration of study participation which is estimated to be 18 months ]
    Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03177668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Official Title  ICMJE Phase I/II 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Mesothelioma
Intervention  ICMJE Drug: YS110
Intravenous administration
Study Arms  ICMJE Experimental: YS110

Phase 1 part: Administration of 3 different dose cohort

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

Intervention: Drug: YS110
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2017)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03177668
Other Study ID Numbers  ICMJE YS1101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nobuo Kanai Kissei Pharmaceutical Co., Ltd.
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP