Clinical trial · Interventional
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates
A Two-cohort, Two-part, Phase 1, Multicenter, Open-label, Fixed-sequence, Drug-Drug Interaction and QTc Assessments of Sitravatinib Followed by Combination Treatment With Nivolumab in Patients With Advanced Solid Malignancies
NCT04887194CI-TRIAL-00076902completedPhase 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)
Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dextromethorphan | Drug | — | UNRESOLVED |
| Digoxin | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Rosuvastatin | Drug | — | UNRESOLVED |
| Sitravatinib | Drug | — | UNRESOLVED |
| Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1, Part 1: Sitravatinib monotherapy (DDI cohort)
- description
- To evaluate the potential for drug-drug interactions (DDI) with sitravatinib monotherapy. To determine the effect of sitravatinib on the pharmacokinetics (PK) of midazolam (CYP3A4 probe substrate), warfarin (CYP2C9 probe substrate), dextromethorphan (CYP2D6 probe substrate), rosuvastatin (BCRP probe substrate), and digoxin (P-gp probe substrate).
- interventionNames
- Drug: Sitravatinib
- Drug: Warfarin
- Drug: Dextromethorphan
- Drug: Midazolam
- Drug: Digoxin
- Drug: Rosuvastatin
- type
- EXPERIMENTAL
- label
- Phase 1, Part 1: Sitravatinib monotherapy (QTc cohort)
- description
- To evaluate the QTc prolongation risk for sitravatinib in patients with advanced/metastatic solid tumors via C-QTc modeling.
- interventionNames
- Drug: Sitravatinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of unresectable advanced/metastatic solid tumor * Life expectancy of at least 3 months * Adequate bone marrow and organ function Exclusion Criteria: * Ongoing medical condition or need for treatment with medication that may affect the PK of study treatments during Part 1 * Immunocompromising conditions * Impaired heart function * Active or prior documented autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.