RET altered solid tumor
Conditions
Interventions
Pralsetinib will be administered orally, once daily at a dose of 400 mg.
Sponsors
Iwasa Satoru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Tolerability assessment part] Histologically or cytologically documented solid tumors ECOG PS of Grade 0 or 1 RET alteration has been identified Advanced or recurrent cancer for which standard therapy is ineffective or for which no standard therapy exists [Continuous administration part] Does not meet the criteria for discontinuation of pralsetinib as defined in pre-transition study protocol
Exclusion criteria
Exclusion criteria: [Tolerability assessment part] Other than RET alteration, known major driver mutations have been identified There has been a history of administration of other selective RET inhibitors [Continuous administration part] Received any anticancer agent between the last dose of pralsetinib in pre-transition study and the first dose of this study in the continuous administration part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, phamacokinetics [Tolerability assessment part] Dose limiting toxicity Safety Pharmacokinetics [Continuous administration part] Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy [Tolerability assessment part] Efficacy based on RECIST v1.1 Relationship between RET alteration and efficacy [Continuous administration part] Not established | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed