Clinical trial · Interventional
Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.
A Phase I, Multi-center, Non-randomized, Open Label, Drug-drug-interaction Study to Determine the Effect of Multiple Doses of Regorafenib (BAY 73-4506) on the Pharmacokinetics of Probe Substrates of Transport Proteins P-gp (Digoxin; Group A) and BCRP (Rosuvastatin; Group B) in Patients With Advanced Solid Malignant Tumors
- 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 regorafenib on the pharmacokinetics of digoxin (P-gp substrate : P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digoxin | Drug | — | UNRESOLVED |
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
| Rosuvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- P-gp probe substrate(digoxin)+regorafenib
- interventionNames
- Drug: Digoxin
- Drug: Regorafenib (Stivarga, BAY73-4506)
- type
- EXPERIMENTAL
- label
- Group B: BCRP probe substrate (rosuvastatin) + regorafenib
- interventionNames
- Drug: Rosuvastatin
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (4)
- measure
- Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for Digoxin
- timeFrame
- On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Inclusion Criteria: * The following criteria apply to ALL patients starting the study treatment: * Patients with histologically confirmed, locally advanced or metastatic solid tumors refractory to standard therapy or in whom regorafenib is considered a standard treatment. * Male or Female Caucasian patients \>/= 18 years of age * Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. * Life expectancy of at leat 12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate bone marrow and liver function * Estimated creatinine clearance (CLcr) ≥ 30 mL/min as calculated using the Cockroft-Gault (C-G) equation. * Thyroid Stimulating Hormone(TSH) within normal ranges. * The following inclusion criteria apply to Group A (digoxin + regorafenib) patients ONLY: * Potassium, magnesium and calcium blood levels within normal range according to the local laboratory. * The following inclusion criteria apply to Group B (rosuvastatin + regorafenib) patients ONLY: * Signed genetic informed consent. Patients must be able to understand and willing to sign the written informed consent intended to screen for BCRP and OATP1B1 polymorphisms. * Exclusion Criteria: * For ALL patients * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication. * Non-healing wound, skin ulcer, or bone fracture. * Ongoing or active infection. * Other anticancer treatment. * Patients unable to swallow oral medications * For Group A (digoxin + regorafenib): * Family history of sudden cardiac death. * For Group B (rosuvastatin + regorafenib): * Patients with porphyria. * Patients with intestinal or urinary obstructions.
References
Publications (0)
Data not yet available