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Completed

NCT Number: NCT03177668

Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

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.

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Key information

Conditions

Malignant Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YS110

Drug

Intravenous administration

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 6, 2017
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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