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Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repaglinide 0.5 mg + Ripretinib 150 mg QD | Experimental | A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ripretinib | Drug | Oral KIT/PDGFRA kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration for Repaglinide | Measure the Cmax | 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. |
| Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide | Measure the AUC0-t | 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. |
| AUC from time 0 and extrapolated to infinity (AUC0-∞) | Measure the 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 | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 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). | Cycle 1 through study completion (~ 12 months). Each cycle is 28 days. |
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Inclusion Criteria:
Exclusion Criteria:
Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
Prior treatment with ripretinib.
Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day 1.
History or presence of clinically relevant cardiovascular abnormalities.
Gastrointestinal abnormalities including but not limited to:
Patients who have type 1 or type 2 diabetes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Sylvester Comprehensive Cancer Center |
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| Repaglinide | Drug | Oral antihyperglycemic agent |
|
| Miami |
| Florida |
| 33136 |
| United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000707850 | ripretinib |
| C072379 | repaglinide |
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