Brief Title
Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Official Title
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Status of onset of Dose Limiting Toxicity (DLT)
Condition
Malignant Pleural Mesothelioma
Intervention
YS110
Study Arms / Comparison Groups
YS110
Description: Phase 1 part: Administration of 3 different dose cohort Phase 2 part: Administration of recommended dose determined from result of Phase 1 part
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
August 8, 2017
Completion Date
February 5, 2020
Primary Completion Date
February 5, 2020
Eligibility 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
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nobuo Kanai, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03177668
Organization ID
YS1101
Responsible Party
Sponsor
Study Sponsor
Kissei Pharmaceutical Co., Ltd.
Study Sponsor
Nobuo Kanai, Study Director, Kissei Pharmaceutical Co., Ltd.
Verification Date
September 2020