Advanced gastrointestinal stromal tumor (GIST)
Conditions
Brief summary
Efficacy: ORR based on Investigator assessment, which is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per the mRECIST
Detailed description
Efficacy: DOR, DCR at 16, 24, and 32 weeks, Time to response, PFS, OS., Safety: TEAEs, SAEs, TEAEs leading to dose reduction, interruption, or discontinuation of any/all study drug(s)., Pharmacokinetics: PK endpoints will be evaluated for DCC-3116, ripretinib, and DP-5439. These PK parameters, if determinable, may include tmax, Cmax, Cmin, AUC.
Interventions
Sponsors
Deciphera Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: ORR based on Investigator assessment, which is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per the mRECIST | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: DOR, DCR at 16, 24, and 32 weeks, Time to response, PFS, OS., Safety: TEAEs, SAEs, TEAEs leading to dose reduction, interruption, or discontinuation of any/all study drug(s)., Pharmacokinetics: PK endpoints will be evaluated for DCC-3116, ripretinib, and DP-5439. These PK parameters, if determinable, may include tmax, Cmax, Cmin, AUC. | — |
Countries
Denmark, France, Germany, Greece, Italy, Netherlands, Portugal, Spain
Outcome results
None listed