Trial Condition(s):

Neoplasms

Effect of regorafenib on digoxin and rosuvastatin in patients with advanced solid malignant tumors.

Bayer Identifier:

16674

ClinicalTrials.gov Identifier:

NCT02106845

EudraCT Number:

2013-003613-18

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
42
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Herne, Germany, 44625

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60488

Status
Completed
 
Locations

Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1083

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1122

Status
Completed
 

Trial Design