Trial Condition(s):
Effect of regorafenib on digoxin and rosuvastatin in patients with advanced solid malignant tumors.
16674
Not Available
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
- 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. -
- 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.
Locations | |
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Locations Investigative Site Herne, Germany, 44625 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Frankfurt, Germany, 60488 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2