Status:
COMPLETED
ONO-4538 Phase I Study in Patients With Solid Tumor
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Advanced Solid Tumors
Recurrent Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refrac...
Eligibility Criteria
Inclusion
- The treatment phase has been completed in the ONO-4538-13 study
Exclusion
- The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
- It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02261298
Start Date
October 1 2014
End Date
April 1 2020
Last Update
May 3 2024
Active Locations (5)
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1
Seongnam-si Clinical Site 105
Seongnam-si, Gyeonggi-do, South Korea
2
Seoul Clinical Site 101
Seoul, South Korea
3
Seoul Clinical Site 102
Seoul, South Korea
4
Seoul Clinical Site 103
Seoul, South Korea