Patients with Advanced Gastrointestinal Stromal Tumors
Conditions
Brief summary
PFS of DCC-2618 based on independent radiologic review using mRECIST criteria.
Detailed description
Efficacy • ORR (confirmed CR + confirmed PR) based on independent radiologic review using mRECIST criteria • OS The primary and secondary endpoints will be analyzed for both the KIT Exon 11 (Exon 11 ITT) and the All Patients (AP ITT) population., Safety Safety endpoints that will be evaluated include treatment-emergent adverse events (TEAEs), SAEs, dose reduction or discontinuation of study drug due to toxicity; and changes from baseline in ECOG PS, vital signs, ECGs, LVEF, dermatologic examinations, and clinical laboratory parameters., Pharmacokinetics • Correlation of PK exposure with efficacy/safety • Population-based PK parameters
Interventions
Sponsors
Deciphera Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficacy • ORR (confirmed CR + confirmed PR) based on independent radiologic review using mRECIST criteria • OS The primary and secondary endpoints will be analyzed for both the KIT Exon 11 (Exon 11 ITT) and the All Patients (AP ITT) population., Safety Safety endpoints that will be evaluated include treatment-emergent adverse events (TEAEs), SAEs, dose reduction or discontinuation of study drug due to toxicity; and changes from baseline in ECOG PS, vital signs, ECGs, LVEF, dermatologic examinations, and clinical laboratory parameters., Pharmacokinetics • Correlation of PK exposure with efficacy/safety • Population-based PK parameters | — |
Primary
| Measure | Time frame |
|---|---|
| PFS of DCC-2618 based on independent radiologic review using mRECIST criteria. | — |
Countries
France, Italy, Netherlands, Norway, Spain
Outcome results
None listed