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Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

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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.

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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: YS110 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arm Intervention/treatment
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

Drug: YS110
Intravenous administration




Primary Outcome Measures :
  1. Status of onset of Dose Limiting Toxicity (DLT) [ Time Frame: 18 days ]
    Assessed by number of subjects with DLT of YS110

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177668


Locations
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Japan
Research Site
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Investigators
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Study Director: Nobuo Kanai Kissei Pharmaceutical Co., Ltd.

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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03177668     History of Changes
Other Study ID Numbers: YS1101
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial