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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003613-18 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-gp probe substrate(digoxin)+regorafenib | Experimental |
| |
| Group B: BCRP probe substrate (rosuvastatin) + regorafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Single dose of digoxin 0.5 mg (2 tablets 0.25 mg) orally without and with regorafenib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for Digoxin | On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15 | |
| Maximum drug concentration (Cmax) in plasma for Digoxin | On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15 | |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for rosuvastatin | On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15 | |
| Maximum drug concentration (Cmax) in plasma for rosuvastatin | On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response following RECIST criteria | From first dose up to 3 months after end of treatment | |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 30 days after last dose |
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Inclusion Criteria:
The following criteria apply to ALL patients starting the study treatment:
The following inclusion criteria apply to Group A (digoxin + regorafenib) patients ONLY:
The following inclusion criteria apply to Group B (rosuvastatin + regorafenib) patients ONLY:
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):
For Group B (rosuvastatin + regorafenib):
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| C559147 | regorafenib |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Rosuvastatin | Drug | Single dose of rosuvastatin 5mg (1 tablet 5 mg) without and with regorafenib 160 mg q.d. (4 tablets 40 mg) |
|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Once daily orally 160 mg (4 tablets 40 mg) |
|
| Number of participants with drug related adverse events as a measure of safety and tolerability | Up to 30 days after last dose |
| Frankfurt am Main |
| Hesse |
| 60488 |
| Germany |
| Herne | North Rhine-Westphalia | 44625 | Germany |
| Budapest | 1083 | Hungary |
| Budapest | 1122 | Hungary |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |