GIST - Gastrointestinal Stromal Tumor
Conditions
Brief summary
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
Interventions
DRUGRepaglinide
Oral antihyperglycemic agent
DRUGRipretinib
Oral KIT/PDGFRA kinase inhibitor
Sponsors
Deciphera Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years of age. 2. Patients must have a histologic diagnosis of GIST. 3. Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies. 4. Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2. 5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements. 6. Adequate organ and bone marrow function.
Exclusion criteria
1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose. 2. Prior treatment with ripretinib. 3. Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day 1. 4. History or presence of clinically relevant cardiovascular abnormalities. 5. Gastrointestinal abnormalities including but not limited to: * inability to take oral medication, * malabsorption syndromes, * requirement for intravenous alimentation. 6. Patients who have type 1 or type 2 diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration for Repaglinide | Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days. | Measure the Cmax |
| Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide | Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days. | Measure the AUC0-t |
| AUC from time 0 and extrapolated to infinity (AUC0-∞) | Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days. | Measure the AUC0-∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | Cycle 1 through study completion (~ 12 months). Each cycle is 28 days. | Adverse events \[TEAEs, SAEs\], dose reduction, dose interruption, or discontinuation, vital signs (heart rate \[beats/min\], and changes in laboratory parameters (chemistry, hematology, urinalysis, coagulation). |
Countries
United States
Outcome results
None listed