ONO-4538 Phase I Study in Patients With Solid Tumor
- Registration Number
- NCT02261285
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- Current or prior severe hypersensitivity to another antibody product
- Multiple primary cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ONO-4538 3mg/kg ONO-4538 ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose ONO-4538 1mg/kg ONO-4538 ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose ONO-4538 10mg/kg ONO-4538 ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose
- Primary Outcome Measures
Name Time Method PK Outcome: Tmax of ONO-4538 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. Tmax was the time to reach the Cmax.
PK Outcome: Cmax of ONO-4538 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. Cmax was the maximum serum concentration of ONO-4538 after the single administration.
AUC21day 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. AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).
AUCinf 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. AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.
T1/2 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. T1/2 was the elimination half-life of serum concentration of ONO-4538.
- Secondary Outcome Measures
Name Time Method Safety Outcome: The Number of Subjects With Overall Adverse Events 3 weeks: from the start of administration to the end of treatment phase. Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product.
Safety Outcome: The Number of Deaths 3 weeks: from the start of administration to the end of treatment phase. Number of subjects with TEAEs leading to death.
Trial Locations
- Locations (5)
Seoul Clinical Site 104
🇰🇷Seoul, Korea, Republic of
Seongnam-si Clinical Site 105
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul Clinical Site 103
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 101
🇰🇷Seoul, Korea, Republic of
Seoul Clinical Site 102
🇰🇷Seoul, Korea, Republic of