Clinical trial NCT02261285: ONO-4538 Phase I Study in Patients With Solid Tumor
Official title: ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Recurrent Solid Tumors
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Increase the dose sequentially.
Primary purpose: TREATMENT

Brief summary: The objective of the study is to investigate the pharmacokinetics 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.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 20 years of age
* Histologically or cytologically confirmed solid tumor
* Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
* ECOG Performance Status is 0 to 1

Exclusion Criteria:

* Current or prior severe hypersensitivity to another antibody product
* Multiple primary cancers

Primary outcomes:
measure: PK Outcome: Cmax of ONO-4538
timeFrame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
measure: PK Outcome: Tmax of ONO-4538
timeFrame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
measure: AUC21day
timeFrame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
measure: AUCinf
timeFrame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
measure: T1/2
timeFrame: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
Secondary outcomes:
measure: Safety Outcome: The Number of Subjects With Overall Adverse Events
timeFrame: 3 weeks: from the start of administration to the end of treatment phase.
measure: Safety Outcome: The Number of Deaths
timeFrame: 3 weeks: from the start of administration to the end of treatment phase.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seongnam-si Clinical Site 105
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 101
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 102
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 103
city: Seoul
country: Korea, Republic of
facility: Seoul Clinical Site 104
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mitsunobu Tanimoto
role: STUDY_DIRECTOR
References:
citation: 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.