ONO-4538 Phase I Study in Patients With Solid Tumor
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
1 other identifier
interventional
18
1 country
5
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 refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2014
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMay 3, 2024
May 1, 2024
8 months
September 30, 2014
May 2, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Safety outcome: The number of subjects with overall adverse events
Approximately 6 months
Safety outcome: The number of deaths
Approximately 6 months
PK outcome: Cmax of ONO-4538
Approximately 10 months
Efficacy outcome: Response rate
Approximately 6 months
Efficacy outcome: Progression free survival
Approximately 6 months
Study Arms (3)
ONO-4538 1mg/kg
EXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 3mg/kg
EXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
ONO-4538 10mg/kg
EXPERIMENTALONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle
Interventions
Eligibility Criteria
You may qualify if:
- The treatment phase has been completed in the ONO-4538-13 study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Seongnam-si Clinical Site 105
Seongnam-si, Gyeonggi-do, South Korea
Seoul Clinical Site 101
Seoul, South Korea
Seoul Clinical Site 102
Seoul, South Korea
Seoul Clinical Site 103
Seoul, South Korea
Seoul Clinical Site 104
Seoul, South Korea
Related Publications (1)
Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20.
PMID: 29158363DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mitsunobu Tanimoto
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
June 1, 2015
Study Completion
April 1, 2020
Last Updated
May 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share