Osteosarcoma
Conditions
Interventions
investigational material(s)
Generic name etc : pamufetinib
INN of investigational material : pamufetinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent or assent Able to take administration orally Histologically confirmed diagnosis of osteosarcoma Unable curative resection due to metastatic lesion Refractory or intolerance to MAP (doxorubicin, cisplatin and Methotrexate) regimen or similar ones Confirmed evaluable lesion based on RECIST version 1.1 R cohort: Primary lesion has been removed completely or performed curative radiation therapy P cohort: Body weight is over 30 kg
Exclusion criteria
Exclusion criteria: Have history of allergic reactions to any component of TAS-115 Prior exposure to TAS-115 or kinase inhibitors Have a serious illness or medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival based on blinded central radiological review, Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival based on clinical investigator, Overall response rate, Time to progression, Time to treatment failure, Disease control rate, 4-month progression-free rate, QOL, Incidence rate and severity of adverse events and treatment- related adverse events, RR interval, PR interval, QRS interval, QT interval corrected using Fridericia formula, Pharmacokinetic parameter | — |
Countries
Japan
Outcome results
None listed