GIST
Conditions
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria - Provided written informed consent - Histologically confirmed GIST. - Have had previous treatments of imatinib, sunitinib and regorafenib - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion criteria
Exclusion criteria: Key exclusion criteria - A serious illness or medical condition - Previous or concurrent cancer that is distinct in primary disease or histology from the cancer that is being evaluated in this study. (Cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia and any previous cancer curatively treated more than 5 years before the enrollment can be eligible.) - Pregnant or lactating female (including the cessation of lactation) or females of child-bearing potential who have a positive pregnancy test proceeded during the Baseline Period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy RECIST(Ver.1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics pharmacogenomics Safety, Pharmacokinetics, Pharmacogenomics CTCAE(Ver.4.03) | — |
Countries
Japan
Outcome results
None listed