GIST
Conditions
Interventions
Dose Escalation Part
-Pimitespib in combination with imatinib
Expansion Part
- Arm A: pimitespib in combination with imatinib
- Arm B: pimitespib followed by imatinib
- Arm C: sunitinib
Pimitespib
Sponsors
Sato Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provided written informed consent - Histologically confirmed GIST - Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy - Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions; - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion criteria
Exclusion criteria: - Corrected visual acuity 5 years before the enrollment can be eligible - Pregnancy or lactation (including lactation interruption)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) and MTD of pimitespib in combination with imatinib Progression-free survival (PFS) by the independent radiological review | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, Adverse drug reaction, Laboratory abnormalities | — |
Countries
Australia, China, Japan, Singapore, Taiwan
Contacts
Public ContactNaoki Arimura
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed