Clinical trial · Interventional
A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST
A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
NCT04530981CI-TRIAL-00080840completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST - Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Repaglinide | Drug | — | UNRESOLVED |
| Ripretinib | Drug | Ripretinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Repaglinide 0.5 mg + Ripretinib 150 mg QD
- description
- 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.
- interventionNames
- Drug: Ripretinib
- Drug: Repaglinide
Primary outcomes (3)
- measure
- Maximum Observed Plasma Concentration for Repaglinide
- timeFrame
- 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.
- description
- Measure the Cmax
- measure
- Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.