Advanced Solid Tumors, Recurrent Solid Tumors
Conditions
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.
Interventions
DRUGONO-4538
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The treatment phase has been completed in the ONO-4538-13 study
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed